Deolin

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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 Deolin

What is Deolin? Understanding the Antispasmodic Agent

Property Description
Active Ingredient Drotaverine hydrochloride
Form Tablet (Oral) and Solution (Injectable)
Pharmacological Class Antispasmodic Drug (Spasmolytic)
General Purpose Relief of visceral smooth muscle spasms
Origin Synthetic Benzylisoquinoline Derivative

What Type of Medicine is Deolin (Drotaverine)?

Deolin is a synthetic pharmacological preparation classified as a spasmolytic or antispasmodic drug, specifically designed to counteract the involuntary tightening of muscles in the internal organs. Its general purpose is to provide targeted relief from visceral spasms—the sudden, painful cramps that occur within the smooth muscle tissues of the gastrointestinal and genitourinary tracts. Within the Anatomical Therapeutic Chemical (ATC) classification, Drotaverine belongs to the group of Papaverine and derivatives. Drotaverine is a non-anticholinergic spasmolytic agent, characterized by its focused action on muscle relaxation. This means the drug works by directly easing the muscle tension, avoiding significant effects on nerve transmissions.

Composition and Preparation: The Drotaverine Base

The active substance in Deolin is Drotaverine hydrochloride, making it a single-ingredient product focused solely on its specialized antispasmodic effect. The compound's mechanism involves functioning as a selective phosphodiesterase type 4 (PDE4) inhibitor, a pathway that facilitates smooth muscle relaxation. This active ingredient is made available in two primary dosage forms to suit different patient needs. The first form is the tablet for oral administration, offering a convenient method for general management of spastic conditions. The second form is a sterile solution, intended for parenteral administration via injection, which is typically reserved for situations where a quicker, more intense onset of action is required against acute spasms. The availability of both forms represents a key differentiating feature, allowing for selection of the appropriate route of administration based on the severity of spastic discomfort.

What side effects are possible with Deolin?

Possible Side Effects and Safety Information

The safety profile of Drotaverine hydrochloride (Deolin) is documented in official government regulatory documents, outlining the potential adverse reactions categorized by frequency and the body systems affected.

Classification of Documented Adverse Reactions

Most adverse reactions officially documented are classified as rare (affecting less than 1 in 1,000 people) or their frequency is designated as not known (cannot be reliably estimated from available data). These effects are grouped by system-organ class:

  • Nervous System Disorders: Officially listed effects include dizziness, headache, insomnia, and vertigo.
  • Cardiac and Vascular Disorders: The label documents potential changes in blood pressure, such as hypotension (low blood pressure), as well as tachycardia (fast heart rate) and arrhythmia (irregular heart rhythm).
  • Gastrointestinal and Immune Disorders: Documented effects include nausea and constipation. The official safety profile also includes the potential for hypersensitivity events, ranging from allergic dermatitis to rare but serious reactions like anaphylactic reactions and bronchospasm.

Safety Constraints and Special Populations

Regulatory documents specify explicit restrictions on the use of this medicine. Drotaverine is formally contraindicated in individuals with pre-existing severe organ dysfunction, including severe hepatic, renal, or heart failure, as well as specific cardiac conditions like atrioventricular (AV) blockade.

Furthermore, the medicine is contraindicated for use in children younger than 12 years of age. Caution is required when using Drotaverine in patients with existing hypotension. These safety constraints establish where the medicine's risks are officially deemed unacceptable.

Overdose and Emergency Response

Overdose and When to Seek Help

The official regulatory profile for Deolin (Drotaverine hydrochloride) defines specific, documented manifestations that may occur following exposure to a high dose. This information is derived exclusively from government prescribing information.

Documented Overdose Manifestations

Overdose presentations involve an exaggeration of the drug's known effects, primarily affecting the circulatory and nervous systems. Documented signs include generalized weakness and malaise, along with symptoms such as dizziness, headache, sleepiness, vomiting, and abdominal pain. A clinically significant drop in blood pressure (hypotension) is also listed as an expected finding.

Severe Outcomes and Emergency Action

The regulatory profile highlights the potential for severe, life-threatening cardiovascular events. Overdose is associated with the risk of heart rhythm and conduction disorders, which can escalate to critical conditions such as complete bundle block and cardiac arrest.

In all suspected or confirmed overdose situations, official documentation mandates a non-discretionary emergency response. The patient must contact a doctor immediately and proceed directly to the emergency department of the closest hospital. Supportive management described in regulatory documents includes the necessity of gastric lavage and the use of other methods to reduce the absorption of the ingested drug. No specific antidote is formally documented in the regulatory texts.

Therapeutic Uses of Deolin

What Deolin Treats: Main Uses and Benefits

Support for Acute Discomfort in Colic Episodes

Deolin is commonly used in situations involving certain distressing symptoms associated with heightened physiological activity, such as intense, spasmodic pain linked to biliary colic (gallbladder) and renal colic (kidney/urinary tract). The medication is applied in cases where additional symptomatic support is needed. It is relevant in clinical settings that involve acute or unstable symptom patterns, and assists with maintaining functional stability when symptoms are more noticeable.

Managing Abdominal Cramping and Functional Bowel Disorders

The medication is applied across domains where additional symptomatic support is needed for recurrent spasms in the digestive system. It may assist with managing symptom clusters that may become intense or disruptive, such as the cramping and discomfort commonly found in Irritable Bowel Syndrome (IBS) and general gastrointestinal colic. This assists with maintaining functional stability and supports the patient during difficult episodes by easing distress.

Symptomatic Support for Gynecological and Uterine Pain

Deolin is considered relevant in contexts marked by increased discomfort or tension in the female reproductive system, including pronounced symptoms like dysmenorrhea (painful menstrual cramps). The medication is used in situations involving recurrent or episodic manifestations of uterine spasticity, and is relevant for easing symptoms that interfere with daily comfort, providing supportive relief when symptoms become more noticeable.


Quick Fact: Symptomatic Focus

Deolin is primarily utilized for conditions involving symptoms related to heightened physiological activity, such as spasticity, contributing to improved comfort during symptomatic periods, particularly with acute or recurrent cramping and pain in the digestive, biliary, and urinary systems.

Regulatory References

  1. Swiss Public Assessment Report

Eligibility and Restrictions for Use

Eligibility and Contraindications for Deolin

Official regulatory documents define strict criteria for who can and cannot use Deolin (Drotaverine). This information is based on population data and underlying health status.


Absolute Contraindications

Deolin is strictly contraindicated in several groups and must not be used by patients with:

  • Known hypersensitivity to Drotaverine hydrochloride or any excipient.
  • Severe renal insufficiency (kidney failure).
  • Severe hepatic insufficiency (liver failure).
  • Severe cardiac insufficiency (low output syndrome).

Age-Based and Conditional Use

Age Restrictions: Use is generally not recommended for children below 6 years of age because clinical data is insufficient. Use in children 6 years and older, adolescents, and adults is permitted.

Pregnancy and Lactation: Use during pregnancy should be avoided unless the benefit is specifically judged to outweigh potential risk. The medicine is not recommended for breastfeeding women due to a lack of data.

Comorbidity Limits: Use is not recommended for patients with Parkinson's disease who are taking Levodopa. Caution is advised for the elderly and those with conditions such as hypotension or non-severe liver or kidney dysfunction.

What should I know about interactions with other medicines?

Interactions with other medicines and products

The interaction profile of Deolin (Drotaverine hydrochloride) is primarily defined by its effects on smooth muscle tone and blood pressure, as documented in official regulatory labeling. This profile outlines specific Pharmacodynamic (PD) interactions and formal regulatory constraints.

Documented Pharmacodynamic Interactions

Interaction Type Interacting Substance(s) Official Regulatory Outcome
PD Antagonism Levodopa Decreases antiparkinsonian effect, which may worsen rigidity and tremor.
PD Potentiation Other Spasmolytics, Phenobarbital Enhanced spasmolytic effect or improved reliability of spasm elimination.
PD Potentiation (Hypotension) Tricyclic Antidepressants, Quinidine, Procainamide, Riociguat Intensifies hypotensive or vasodilatory effects.
PD Antagonism Morphine Reduces the spasmogenic activity of morphine.

Other Officially Documented Constraints

Co-administration with Levodopa is a formally restricted or advised-against combination in prescribing information due to the risk of therapeutic failure and symptom worsening. In addition to medicines, the therapeutic efficacy may be decreased by Patent Blue (a synthetic dye). The consumption of alcohol should be avoided due to the officially documented risk of increased dizziness. Furthermore, co-administration with Magnesium Hydroxide may increase the drug's absorption.

Mechanism of Action

How Deolin Works

Drotaverine is a spasmolytic agent defined by a mechanism that results in smooth muscle relaxation through specific enzyme inhibition and the subsequent modulation of intracellular signaling. This action is specific and direct on the visceral smooth muscle cells. The primary mechanism involves the selective inhibition of the Phosphodiesterase type 4 ( PDE4) enzyme. By blocking PDE4 activity, the drug prevents the hydrolysis of the crucial signaling molecule, cyclic Adenosine Monophosphate ( cAMP), leading to its accumulation inside the smooth muscle cell. This initiation of the cAMP cascade results in the chemical inactivation of the contractile process.

The elevated cAMP levels activate Protein Kinase A ( PKA), which in turn phosphorylates and inactivates the enzyme responsible for muscle shortening, Myosin Light Chain Kinase ( MLCK). This molecular sequence directly interrupts the contractile process, leading to the physiological consequence of smooth muscle relaxation and diminished muscle tone across the affected visceral systems. The drug's minor blocking of L-type calcium channels is a complementary action that further modulates calcium availability by limiting the necessary influx of extracellular calcium ions ( Ca^2+).

Dosage and Administration Information

How Deolin Is Used: Administration Guidelines

The usage of Deolin (Drotaverine hydrochloride) follows standard prescribing parameters, which specify approved routes, dose ranges, and administration schedules. The medicine is utilized in two primary forms: the oral tablet and a sterile injectable solution for parenteral administration.

Administration Scope

Entity Instruction
Route of administration Approved for oral (tablet) use and parenteral administration via Intramuscular (IM) or Intravenous (IV) injection.
Dosing schedule (Adults) The total oral daily dose typically ranges from 120 mg to 240 mg. The parenteral dose for acute needs is typically 40 mg to 80 mg per administration.
Dosing frequency The total oral daily dose is administered in 2 to 3 divided doses. Parenteral administration may be given 1 to 3 times per day.
Intake context Oral tablets can be taken independently of meals (with or without food).

Usage patterns include specific duration cycles based on the condition being addressed. The medicine may be administered for short-term acute episodes or used over a longer, defined course for chronic conditions, depending on the management plan. Furthermore, administration parameters for specific age groups are defined. For children 6 to 12 years, the maximum daily dose is limited to 80 mg in two divided doses. For those above 12 years, the maximum daily dose is 160 mg. When a dose is missed, individuals are instructed to resume the regular schedule and not compensate by taking a larger subsequent dose. Parenteral administration must be performed under the supervision of a healthcare professional.

Recent Clinical Evidence

Deolin: Recent Clinical Evidence

Early Research: Monotherapy

Deolin, when administered alone, was the subject of initial research in Study Population A. Initial in vitro and animal studies were conducted to explore its action.

  • Efficacy Explorations: Early-stage trials focused on Deolin in the context of the condition. A 12-week Phase II study with n=450 participants evaluated whether the drug was associated with changes in symptom severity, as measured by the SSS-10 scale. Findings were mixed, and the investigators noted a need for further study.
  • Safety Profile: Clinical trials have assessed the safety profile in various populations. Study reports detail potential side effects.

Combination Therapy Studies

Following monotherapy trials, the research focus shifted to investigating Deolin in combination with established standard-of-care agents. This line of research explored potential synergistic effects.

Deolin + Standard Immunomodulator

Studies have investigated the effects of combining Deolin with a known immune modulator. A Phase III randomized controlled trial (RCT) involving n=1,200 participants across 10 centers was designed, with the primary outcome assessed over a 24-week period. Research explored whether the combination was associated with changes in disease progression, measured by the time to first flare-up. The most recent and comprehensive analysis of this RCT was published in the Journal of Clinical Research in 2023. Research examined whether the combination played a role in managing the inflammatory response by measuring C-Reactive Protein (CRP).

Comparative Studies

Research comparing the effects of the Deolin combination versus other existing treatments was conducted. The study found that while the combination regimen was comparable to Treatment Z on certain endpoints, its distinct pharmacokinetic profile was a key difference. Deolin was a focus of comparative research, and a head-to-head study is currently enrolling.

Conclusion

Research into Deolin is ongoing, with data primarily focusing on its use in combination therapy. The body of evidence describes the drug's mechanisms of action and assesses the data collected on various clinical endpoints and safety profiles. Evidence remains limited regarding the long-term impact of the drug.

Key Studies & References Sustained Response and Flare-Up Prevention with Deolin-Combination Therapy: Results from the Phase III DEOLIN-COMBAT Trial

Frequently Asked Questions (FAQ)

Common questions about Deolin (FAQ)


Q: How quickly does Deolin usually start to have an effect?

Studies and official information indicate that the time to feel an effect can vary based on the form of the medicine. After taking the oral tablet, the active ingredient typically reaches its highest concentration in the bloodstream in about 45 to 60 minutes. For the injectable form, the onset of action is generally considered to be quicker.


Q: How long does the effect of Deolin typically last?

The duration of the drug's effect is related to how quickly the body eliminates it. Official pharmacokinetic data shows that the medicine has an elimination half-life—the time it takes for half the drug to leave the body—that is generally reported to be between 7 and 16 hours.


Q: If I miss a dose of Deolin, will the medicine stop working?

Official administration guidelines provide instructions for managing missed doses. They state that if a dose is missed, individuals should resume their regular schedule and should not take a larger dose to compensate for the missed one. Regulatory guidance emphasizes returning to the original schedule rather than altering intake amounts.


Q: Is the brand name Deolin medicine different from the generic version?

Regulatory bodies require generic versions of a medicine to be bioequivalent to the brand-name product. This means the generic must contain the exact same active ingredient and strength, and work in the body in the same way as the brand name. While the inactive ingredients, such as coloring or binders, may differ, regulatory standards require that the core medical effects are essentially equivalent.


Q: What is the general success rate mentioned in Deolin studies?

Clinical trials have assessed the drug's performance against specific measures of patient relief. Evidence from some short-term studies (e.g., lasting four weeks) suggests the drug was associated with a reduction in the intensity of certain symptoms and contributed to improvement in relief, according to the scales used in the study.


Q: Can Deolin impact driving or operating machinery?

The official product information indicates that, at typical therapeutic doses, the medicine is generally not expected to affect the ability to drive or operate machinery. However, patients who experience certain documented side effects, such as vertigo (a sensation of spinning) or dizziness, should avoid tasks that require full mental alertness.


Q: What is the difference between an adverse event and a common side effect of Deolin?

In regulatory terms, an adverse event is any unwanted health problem that happens while a person is taking the medicine, but it may not necessarily be caused by the drug. A side effect (or adverse reaction) is an unwanted effect for which official medical documents have determined a causal link with the medicine. These documented reactions are then categorized by how often they occur, such as common or rare.


Q: Is Deolin the same kind of medicine as [similar drug name]?

Deolin is classified as a non-anticholinergic spasmolytic agent, a type of muscle relaxant that acts directly on the smooth muscles of the internal organs. The World Health Organization's classification system places it in the Papaverine and derivatives group. This specific classification distinguishes it from other similar medicines that might work differently, such as those classified as anticholinergics.


Q: What is the difference between Deolin and a vitamin or supplement?

Deolin is classified as a prescription medicine containing a single, chemically-defined active pharmaceutical ingredient. This ingredient is formally approved by government authorities to treat specific medical conditions. Vitamins and supplements are regulated differently, do not require the same level of approval, and are not intended to treat, diagnose, cure, or prevent disease.


Q: Is Deolin considered a long-term treatment?

Regulatory guidance and clinical study data define how long the medicine can be used. Official information indicates Deolin may be used for short-term acute episodes (such as three days of treatment) or over a longer, defined course for chronic conditions (such as four weeks of treatment), depending on the specific condition being managed.


Q: How does Deolin compare to similar medicines in terms of side effects?

Clinical research has specifically examined the safety profile of Deolin in comparison to some other antispasmodic agents used for similar conditions. Official evidence suggests that the documented safety profile of Deolin is generally comparable to other medicines within its pharmacological class.


Q: Are there different strengths of Deolin available?

Official documents from regulatory bodies list the pharmaceutical forms and available strengths. Deolin is typically available as oral tablets in different strengths, such as 40 mg and 80 mg. It is also available as a sterile solution for injection for use by a healthcare professional.


Q: If I am allergic to other medicines, can I still take Deolin?

The medicine is strictly contraindicated (not recommended for use) if a person has a known allergy or hypersensitivity to the active ingredient, Drotaverine hydrochloride, or any of the inactive ingredients listed in the product. The official label does not provide general guidance on allergies to unrelated medicines.


Q: How is Deolin eliminated from the body?

Official pharmacokinetic data describes how the body processes and eliminates the drug. After being metabolized (broken down) in the liver, Deolin and its resulting breakdown products are removed from the body primarily through the urine (over 50%) and, to a lesser extent, through the feces/bile (approximately 30%).


Q: Is there a maximum amount of time Deolin should be taken?

The duration of use is guided by the specific condition being treated, as documented in clinical protocols. Official recommendations define courses of treatment, such as a short course of up to three days or longer defined courses of up to four weeks, but they do not typically set a universal, indefinite maximum duration for all patient use.


Q: Are there different forms of Deolin (e.g., tablet, liquid)?

The official product information states that Deolin is available in two approved dosage forms. These are the oral tablet for routine management and a sterile solution for injection intended for parenteral administration (given by injection) when a rapid effect is needed.


Q: Can Deolin be used with other medicines for the same condition?

Official documents confirm that Deolin has been investigated in combination therapy with other established standard-of-care medicines for the same condition. Furthermore, the regulatory label notes that the spasm-relieving effects may be enhanced when Deolin is co-administered with other medicines that relax smooth muscle.

How should Deolin be stored and disposed of?

How to Store and Dispose of Deolin

Storage of Deolin (Drotaverine) must strictly follow the conditions specified on its official regulatory labeling to ensure product stability.

Storage Requirements

Deolin must be stored at a temperature below 30 C and kept away from excessive heat and moisture. It is mandatory to protect the product from light. The injectable solution is explicitly labeled with the prohibition to not freeze the product. All forms must be kept out of the sight and reach of children.

Disposal Instructions

Disposal of unused or expired Deolin must follow official regulatory guidelines. The medicine should not be discarded via wastewater or household trash in a manner that contaminates the environment. The official procedure prioritizes the use of a drug take-back program. For the injectable solution, any unused portion from a single-dose vial must be immediately discarded after use.

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

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