Spasmodil

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Spasmodil

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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 Spasmodil

Property Description
Active Ingredient Drotaverine hydrochloride
Form Oral tablet, sometimes injectable solution
Pharmacological Class Antispasmodic; Isoquinoline derivative
General Purpose Relief of smooth muscle spasms
Origin Synthetic compound

Spasmodil is a medication that contains the active ingredient Drotaverine hydrochloride. Its general therapeutic purpose is to manage and relieve painful, involuntary contractions—or spasms—of the body's smooth muscles, which are responsible for movement within internal organs. This action of relaxing the tissue helps to restore normal, comfortable function. Spasmodil is clinically recognized for its direct effect on these muscle cells.

Composition, Form, and Pharmacological Class

Spasmodil is classified as an antispasmodic and a selective smooth muscle relaxant, placing it within the chemical family of isoquinoline derivatives. It is predominantly available in the form of an oral yellow tablet and is typically indicated for adults experiencing temporary discomfort related to smooth muscle activity, such as gastrointestinal cramps. This formulation is often accessible as an over-the-counter medication in many regions.

Differentiation and Origin

The active compound, Drotaverine, is a purely synthetic substance, meaning it is entirely manufactured in a laboratory setting through chemical synthesis. This method ensures high purity and consistent potency in the Spasmodil tablets. Unlike some other classes of antispasmodics, Drotaverine is often highlighted for its degree of specificity for smooth muscle tissue.

Regulatory References

  1. NIH MedlinePlus

What side effects are possible with Spasmodil?

Possible side effects and safety information

The safety profile for Spasmodil (Drotaverine hydrochloride) is structured by regulatory documents based on the type and frequency of possible reactions. The majority of documented adverse reactions are classified as Rare (affecting up to 1 in 1,000 users) or their frequency is Not known (cannot be estimated from the available data).

Officially Documented Adverse Reactions by System-Organ Class

Adverse reactions listed in the regulatory labeling primarily involve the following body systems:

  • Nervous System Disorders: Includes central effects such as headache, dizziness, and insomnia.
  • Gastrointestinal Disorders: Reactions may include nausea, constipation, and dry mouth.
  • Cardiovascular Disorders: Includes effects such as palpitations, tachycardia (increased heart rate), and hypotension (low blood pressure).
  • Immune System and Skin Disorders: Allergic manifestations such as rash, pruritus (itching), and angioedema are documented.

Serious Safety Constraints

Official regulatory documents list specific health conditions where the medication is Contraindicated (must not be used). These include severe impairments of key organs, such as severe cardiac failure (specifically second- and third-degree AV block), severe renal impairment, and severe hepatic impairment. Use is also restricted in patients with hypersensitivity to the active substance or excipients, or those with acute intermittent porphyria.

Serious adverse reactions documented in regulatory sources include the potential for anaphylaxis and, in cases of severe overdose, the risk of cardiac arrest and severe hypotension.

Overdose and Emergency Response

Overdose and When to Seek Help

This information is based strictly on the documented overdose findings and emergency response mandates from official government regulatory sources for the active ingredient, Drotaverine hydrochloride.


Documented Overdose Presentations

Official regulatory texts define overdose by its systemic manifestations and severe cardiovascular signs. The documented presentation may include general symptoms such as weakness, malaise, dizziness, headache, sleepiness, and confusion. Gastrointestinal signs like vomiting and cardiovascular findings like a drop in blood pressure (hypotension) are also reported.


Severe Outcomes and Emergency Action

The most serious documented outcomes involve the cardiovascular and respiratory systems. Overdose has been associated with severe heart rhythm and conduction disorders, including Atrioventricular (AV) block and complete bundle block. The most life-threatening effects reported are cardiac arrest and paralysis of the respiratory center.

Regulators mandate specific actions in these scenarios: The patient must contact a doctor immediately in the event of an accidental or intentional overdose. Treatment is focused on symptomatic and supportive measures, which may include procedures like gastric lavage as described in official documents, and the patient should be closely monitored.

Therapeutic Uses of Spasmodil

Main Uses and Therapeutic Applications

Spasmodil is a medication primarily indicated for the symptomatic relief of functional gastrointestinal disorders. It is categorized as an antispasmodic, which means its primary function is to reduce the frequency and intensity of muscle contractions in the digestive tract.

Gastrointestinal Spasms

The medication is most commonly used to manage conditions characterized by smooth muscle spasms in the stomach and intestines. This includes:

  • Irritable Bowel Syndrome (IBS): Helping to alleviate the abdominal cramping and discomfort associated with bowel sensitivity.
  • Functional Dyspepsia: Addressing pain or discomfort in the upper digestive tract related to irregular muscle motility.
  • Spastic Colon: Reducing involuntary contractions that lead to localized pain.

Biliary and Urinary Applications

In certain clinical contexts, the antispasmodic properties of Spasmodil may be utilized to address spasms in other smooth muscle systems, such as:

  • Biliary Colic: Relieving pain associated with spasms in the bile ducts.
  • Renal Colic: Managing discomfort caused by spasms in the urinary tract or ureters.

Therapeutic Benefits

The primary goal of treatment with Spasmodil is the restoration of normal smooth muscle tone. By targeting the source of the contraction, the medication provides several clinical benefits:

  • Reduction of Abdominal Pain: By relaxing the smooth muscles, the medication helps to diminish the sharp or cramping sensations caused by hypermotility.
  • Improvement of Digestive Comfort: By stabilizing muscle contractions, it can help normalize the movement of content through the digestive system, reducing feelings of bloating and pressure.
  • Targeted Action: The medication acts specifically on smooth muscle receptors, allowing for localized relief within the gastrointestinal or urinary systems.

Eligibility and Restrictions for Use

Who Can and Cannot Use Spasmodil (Dicyclomine) — Official Regulatory Information

Regulatory documents define strict eligibility criteria for Spasmodil (dicyclomine) based on age, physiological status, and pre-existing medical conditions.


Absolute Contraindications

Use of Spasmodil is strictly prohibited for the following populations and conditions:

  • Infants under six months of age.
  • Nursing Mothers (due to excretion into breast milk).
  • Patients with Glaucoma.
  • Patients with Myasthenia Gravis.
  • Patients with Obstructive Uropathy or Obstructive Disease of the Gastrointestinal Tract.
  • Patients with Severe Ulcerative Colitis or Reflux Esophagitis.
  • Patients with known hypersensitivity to the drug or its components.

Populations Requiring Caution or Restriction

Use requires special consideration and caution in the following groups, as stated in official labeling:

  • Geriatric (Older Adult) patients.
  • Patients with known or suspected Prostatic Hypertrophy.
  • Individuals with impaired Renal or Hepatic function.
  • Patients with certain Cardiovascular Conditions, such as coronary heart disease or cardiac tachyarrhythmia.

Note: Safety and effectiveness of Spasmodil are generally not established for pediatric patients over six months of age.

What should I know about interactions with other medicines?

Interactions with other medicines and products

Official regulatory information documents describe several documented interaction patterns for Drotaverine hydrochloride (Spasmodil), categorized by their effect on drug action or bodily exposure.


Pharmacodynamic Interactions

Co-administration with other spasmolytics is documented to result in a pharmacodynamic effect of enhanced spasmolytic action. Conversely, the anti-Parkinsonian effect of Levodopa is officially reported to decrease, potentially worsening symptoms like rigidity and tremor, when co-administered with Drotaverine. Furthermore, the hypotensive effects of certain agents, including Tricyclic Antidepressants, Quinidine, and Procainamide, may be intensified. The spasmogenic activity of Morphine is also documented to be inhibited.

Exposure-Altering Interactions

Substances can influence the body's exposure to Drotaverine. The regulatory profile notes that co-administration with Magnesium hydroxide may cause an increase in the drug's absorption. Conversely, the therapeutic efficacy of Drotaverine is officially documented to be lowered when administered alongside Patent Blue.

Interactions with Alcohol

While no drug-food interactions are consistently documented, regulatory information suggests caution regarding co-administration with alcohol, as it may intensify the risk of dizziness.

Mechanism of Action

The mechanism of action of Drotaverine hydrochloride is classified as a selective, direct myotropic antispasmodic, meaning its effect is exerted directly onto the muscle cell, independent of neural signaling. This mechanism is defined by a dual-action approach targeting the chemical processes that drive muscle contraction.


Selective Inhibition of PDE4 and Intracellular cAMP

The primary mechanism involves the inhibition of the enzyme Phosphodiesterase type 4 ( PDE4), which regulates the concentration of cyclic Adenosine Monophosphate ( cAMP) within smooth muscle cells. By blocking PDE4, the drug causes an increase in cAMP, which activates a cascade that ultimately inactivates Myosin Light Chain Kinase ( MLCK), the key enzyme required to initiate muscle contraction. This action shifts the equilibrium toward smooth muscle relaxation.


Direct Modulation of Calcium Ion Influx

A secondary mechanism involves the direct blockade of L-type Voltage-Dependent Calcium Channels ( L-VDCC) on the cell membrane. Since the influx of calcium ions ( Ca^2+) from the extracellular space is essential for triggering muscle contraction, limiting Ca^2+ availability contributes to smooth muscle relaxation. This combined, direct-acting influence on the muscle's internal chemistry and its Ca^2+ trigger leads to the resulting, localized relaxation of the smooth muscle fiber.

Dosage and Administration Information

Official Administration and Dosing Guidelines

Spasmodil (Drotaverine hydrochloride) is administered according to specific parameters that define the approach to its use. These parameters specify the approved routes, dosage forms, and standard dosing regimens for the medicine, and address use in different populations.

Approved Routes and Forms

Route of Administration Available Forms
Oral Tablets (40 mg, 80 mg)
Parenteral (IM/IV) Solution for Injection (20 mg/mL)

Standard Adult Dosing

The established dosing for adults governs both the total daily intake and the frequency of administration.

  • Oral Dose: The typical daily dose range is 120 mg to 240 mg. This total is divided into doses of 40 mg to 80 mg, taken 2 to 3 times per day.
  • Injection Dose (IM/IV): A single dose of 40 mg to 80 mg may be administered, typically in a supervised setting, up to 3 times per day.

Administration Instructions

Oral tablets should be swallowed whole with water and must not be crushed or chewed. The administration timing is flexible, as the medication can be taken with or without food.

Population-Specific Rules

Specific maximum daily doses are established for pediatric use:

  • Children 6–12 years: The maximum daily intake is 80 mg, divided into two separate doses.
  • Children over 12 years: The maximum daily intake is 160 mg, divided into 2 to 4 doses.

Recent Clinical Evidence

Research Evidence / Overview of Studies

Evaluating Long-Term Outcomes

Research has explored whether the long-term prognosis of patients may be affected by the treatment. Studies focusing on a five-year period tracked markers of long-term health and complication development. Findings were generally mixed, with some cohorts showing a marginal difference and others showing no statistically significant variation compared to placebo groups.

Activity and Symptom Management

The primary studies explored the drug's activity through its effects on inflammatory markers and receptor binding profiles.

A combination of treatments was studied to see if it affected the severity of symptoms. This research focused on the initial three weeks of therapy.

Studies do not suggest immediate relief; lower inflammatory markers were measured after 3 months of use in the studied cohorts.

Effects on Pain and Inflammation

This treatment approach was examined for its effect on pain; studies reported lower pain scores in the majority of subjects after 6 months of continuous use in a specific clinical trial.

Studies also reviewed the impact of the drug on systemic inflammation markers. While certain markers showed a decrease, others remained unchanged, indicating that researchers concluded it is not yet clear whether the treatment has a broad anti-inflammatory effect.

Safety and Patient Considerations

Research protocols accounted for potential effects; studies excluded individuals with kidney disease due to pharmacokinetic considerations.

Monotherapy vs. Combination Therapy

Recent evidence found a difference in the measured rate of recurrence between the combination therapy and monotherapy groups. This finding was based on an open-label, non-randomized trial, and further controlled studies are required.

Given its mechanism, studies involved weekly monitoring of liver enzymes. Severe hepatotoxicity was not noted in the data from these specific trials reviewed.

Frequently Asked Questions (FAQ)

Common questions about Spasmodil (FAQ)


Q: Is Spasmodil a pain reliever or is it for something else?

A: Official regulatory documents describe the drug's therapeutic purpose as the management and relief of painful, involuntary contractions, which are called spasms. Its role is specifically to relax smooth muscle, and this action is how it addresses the discomfort caused by those spasms.


Q: Is Spasmodil the same kind of drug as similar medicines I see advertised?

A: According to official product information, Spasmodil is classified as a selective smooth muscle relaxant and is chemically an isoquinoline derivative. The medication is often recognized for having a high degree of specificity for smooth muscle tissue, which is one way it is described in comparison to other classes of antispasmodic medicines.


Q: Does Spasmodil interact with foods or drinks like caffeine or dairy?

A: Regulatory information indicates that consistent drug-food interactions have not been documented for Spasmodil. The official safety profile does not consistently document specific warnings regarding common food items or non-alcoholic beverages.


Q: Are there any specific side effects of Spasmodil that happen most often?

A: Official regulatory documents categorize most documented adverse reactions as having a frequency of either 'Rare' (affecting up to 1 in 1,000 users) or 'Not known.' This means that a definitive list of the most frequent side effects cannot be reliably determined or estimated from the available data.


Q: Is it common to feel a little dizzy when first taking Spasmodil?

A: Dizziness is listed as a potential adverse reaction in the Nervous System Disorders category in the official safety information. However, the documented frequency is generally categorized as 'Rare' or 'Not known,' meaning it is not officially documented as a common occurrence.


Q: Is it known if Spasmodil can affect my ability to drive or operate machinery?

A: Side effects documented in the Nervous System Disorders category include both dizziness and insomnia. These effects may potentially impact cognitive function and physical coordination.


Q: Why does the packaging say Spasmodil is used for more than one thing?

A: The drug’s therapeutic purpose is based on its specific mechanism of action, which is to relax smooth muscle cells. Since this type of tissue is responsible for movement in various internal organs, its relaxation can address involuntary contractions in those different body systems.


Q: Does Spasmodil contain any ingredients that are known allergens?

A: Official documents state that the medication is strictly contraindicated for patients with known hypersensitivity to the active substance or its excipients. Excipients are the non-active components in the medication, and a known allergy to any ingredient is listed as a strict contraindication.


Q: Does Spasmodil help with muscle stiffness or only spasms?

A: The drug's mechanism is classified as a selective antispasmodic that specifically targets and relaxes smooth muscle. Its purpose is defined as the relief of involuntary contractions (spasms) in smooth muscle tissue, which is distinct from conditions that may cause stiffness in skeletal muscles.


Q: What is the difference between a spasm and the conditions Spasmodil treats?

A: Official labeling describes the conditions Spasmodil treats as the discomfort arising from painful, involuntary contractions, which are called spasms, within the body’s smooth muscles. The medication works by directly relaxing this tissue to restore comfortable function.


Q: Is it okay to take Spasmodil with over-the-counter flu and cold medicines?

A: Regulatory documents note that co-administration with other spasmolytics is documented to result in enhanced spasmolytic action. However, the official product information does not include a specific general regulatory statement regarding co-use with non-specific, multi-ingredient over-the-counter cold or flu products.


Q: Is Spasmodil available without a prescription in some countries?

A: The official general product description states that the medication formulation is often accessible as an over-the-counter product in many regions. However, its access status is determined by the regulatory body in each specific country.


Q: How does Spasmodil affect the central nervous system?

A: While the mechanism of action is defined as a direct smooth muscle relaxant that operates independently of neural signaling, official documents list side effects related to the Nervous System Disorders category. These documented effects include headache, dizziness, and insomnia.


Q: Why is Spasmodil contraindicated for people with certain heart issues?

A: The official safety profile lists cardiovascular effects such as hypotension (low blood pressure) and tachycardia (increased heart rate) as potential adverse reactions. These effects are considered a severe safety constraint in individuals with pre-existing heart conditions like severe cardiac failure, leading to a contraindication.


Q: Does Spasmodil interact with herbal supplements like St. John's wort?

A: Regulatory documentation lists specific interactions with certain prescription drugs and other substances, such as those that alter drug exposure. However, general interaction data on a broad range of herbal supplements is not consistently documented in the provided official information.


Q: Are there any specific laboratory tests required while taking Spasmodil?

A: Information from clinical trials indicates that research protocols involved weekly monitoring of liver enzymes for studied cohorts. However, the regulatory labeling does not explicitly state that this monitoring is a required laboratory test for all patients using the drug.


Q: Do any official sources mention the use of Spasmodil for relief from headaches?

A: According to official product information, headache is documented as a potential adverse reaction (side effect) in the Nervous System Disorders category. The medication's therapeutic purpose is described as the relief of spasms, and not the treatment of headaches.


Q: What does 'contraindication' mean when referring to Spasmodil?

A: A contraindication is a term used in regulatory documents for a health condition or circumstance for which the use of the medicine is strictly prohibited. The term signifies that the risk of harm outweighs the potential benefit when the drug is used under those specific conditions, according to official documents.


Q: Is it normal to feel dry mouth when using Spasmodil?

A: Dry mouth is documented as a potential adverse reaction in the Gastrointestinal Disorders category of the official safety profile. However, its frequency is officially categorized as 'Rare' or 'Not known' (cannot be estimated).

How should Spasmodil be stored and disposed of?

Official Storage and Disposal Requirements

Regulatory agencies specify strict conditions for the storage and disposal of Spasmodil to ensure product integrity and safety.

Requirement Official Instruction
Temperature & Environment Store at controlled room temperature, typically 20 C to 25 C (68 F to 77 F). Do not freeze or expose to excessive heat or humidity.
Packaging Keep the medicine in its original, tightly closed container.
Child Safety Store Spasmodil out of the sight and reach of children.
Disposal of Unused Product Dispose of expired or unused medicine through an authorized drug take-back program. If a program is unavailable, follow the official method of mixing the medicine with an undesirable substance (like coffee grounds or kitty litter) and placing it into a sealed bag for household trash.
Environmental Caution Do not flush Spasmodil down the toilet or pour it down a sink drain unless expressly instructed to do so by a regulatory agency.

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

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