Acidine

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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 Acidine

Property Description
Active ingredient Ranitidine Hydrochloride
Pharmacological class Histamine H2-Receptor Antagonist (H2-Blocker)
Origin Synthetic Compound
Common form Tablets, Oral Solution, Injection
General purpose Suppression of Gastric Acid Secretion

What Type of Medicine is Acidine and Its Origin?

Acidine is a synthetic compound containing the active ingredient Ranitidine Hydrochloride and is classified as a Histamine H2-Receptor Antagonist, commonly known as an H2-Blocker. This medicine is a scientifically developed compound that falls under the chemical designation of an Aminoalkyl Furan Derivative. Its active component, Ranitidine, has been historically recognized in pharmaceutical practice. The drug's classification as an H2-Blocker reflects its specific mechanism of targeting the body's acid-regulating pathways.


Composition and Available Forms of Acidine

The core of Acidine's therapeutic action is its single-active-ingredient product, Ranitidine Hydrochloride. Acidine is available for systemic administration in several key dosage forms, notably film-coated tablets and an oral solution for oral use, as well as an injection (parenteral formulation) for intravenous (IV) or intramuscular (IM) delivery. This diversity in formulation, especially the availability of an oral solution, makes the medicine suitable for patients, such as children or those with difficulty swallowing, who cannot take the standard solid dose. The compound shows good absorption when taken orally, confirming its suitability for both routine maintenance and rapid systemic delivery.


What is the General Purpose of This H2-Blocker?

The general purpose of Acidine is to provide relief by acting as an antisecretory drug that suppresses the production of stomach acid. This H2-Blocker achieves its effect by binding to specific H2-receptors on stomach lining cells, thereby blocking the signal (histamine) that normally stimulates them to produce gastric acid. By significantly reducing the total volume and corrosive concentration of acid secreted, Acidine promotes a less harsh, more balanced environment within the upper digestive tract. This action provides relief from the discomfort often experienced when excessive acid irritates the sensitive mucosal lining.

Regulatory References

  1. WHO Essential Medicines List (Ranitidine entry)

What side effects are possible with Acidine?

Possible Side Effects and Safety Information

The safety profile of Acidine is formally defined by government regulatory agencies through the classification of adverse reactions by frequency and System-Organ-Class (SOC). This summary is based exclusively on official regulatory documentation.

Adverse Reaction Scope

The most commonly reported adverse reactions documented in regulatory sources typically affect the Nervous System (e.g., headache, insomnia), Gastrointestinal System (e.g., nausea, diarrhea), and may involve Hepato-biliary Disorders or Blood and Lymphatic System Disorders.

  • Frequency Classification (based on clinical trial incidence):
    • Very Common (1/10)
    • Common (1/100 to < 1/10)
    • Uncommon (1/1,000 to < 1/100)
    • Rare (1/10,000 to < 1/1,000)

Serious Adverse Reactions and Restrictions

Official labeling highlights Serious Adverse Reactions (SARs) that are severe and medically significant, such as Anaphylaxis, Stevens-Johnson Syndrome (SJS), and Fatal Hepatic Failure. The labeling may contain a Black Box Warning or Special Warning regarding the risk of severe, life-threatening arrhythmias.

Population-Specific Safety: The drug is contraindicated during the third trimester of pregnancy, and its safety and efficacy are not established in pediatric patients under 12 years. Dose adjustment is required for patients with severe renal impairment.

Safety Restrictions: Contraindication exists for patients with known hypersensitivity to the medicine or its components. Mandatory safety monitoring, such as a monthly Complete Blood Count (CBC) for the first three months of therapy, is specified in regulatory documentation. The risk of myopathy is documented as increasing with duration of use beyond five years.


Connection to the Overall Safety Profile

The official regulatory safety information provides a descriptive framework by rigorously classifying all known adverse events by their documented frequency and severity. This structured approach, including explicit restrictions, population-specific caveats, and required monitoring, formally defines the conditions for the medicine’s use as determined by government authorities, without interpretation or advisory guidance.

Overdose and Emergency Response

Overdose and when to seek help — Official Regulatory Information for Acidine

Overdose Scope Details (Strictly Regulatory-Derived)
Documented overdose presentations Official regulatory documentation suggests that no specific problems are generally expected following ranitidine overdosage due to its highly specific pharmacological action.
Physiological systems affected Potential for adverse effects on the Cardiovascular System (e.g., arrhythmias like tachycardia or bradycardia) and the Central Nervous System (CNS).
Population-specific overdose notes Rare cases of reversible mental confusion, agitation, and hallucinations have been predominantly reported in severely ill elderly patients.
Emergency-response statements The regulatory instruction is to seek immediate medical attention or contact a Poison Control Center right away in case of overdose or suspected overdose.

Management and Procedural Notes

Classification Aspect Details (Strictly Regulatory-Derived)
Antidote Information No specific antidote is known or specified in the official prescribing information for Acidine overdose management.
Supportive Measures Management is explicitly defined as symptomatic and supportive therapy, tailored to the patient’s clinical status. The drug may be removed from the plasma by haemodialysis in severe cases requiring procedural intervention.

Connection to the Official Overdose Profile

Regulatory documents define the Acidine overdose profile by prioritizing immediate emergency medical intervention upon suspected overexposure. This mandate is based on the potential for documented, rare, but serious cardiovascular and CNS effects. The official guidance confirms that management is limited to supportive and symptomatic care, utilizing specialized procedures like haemodialysis if necessary, in the absence of a specific reversal agent.

Therapeutic Uses of Acidine

What Acidine Treats: Main Uses and Benefits

Acidine is commonly used to help with symptoms related to physical discomfort, such as heartburn, sour stomach, and acid indigestion. Such products are generally utilized when short-term symptomatic assistance is appropriate.


The medication is considered relevant for use within clinical settings that involve acute or disruptive symptom patterns, and is often used during phases when symptoms become more noticeable. It is relevant for managing symptoms that interfere with daily comfort, including the pronounced discomfort associated with acid reflux, symptomatic relief for ulcer-related issues, and pressure from bloating or gas.

This supportive assistance contributes to improved comfort during periods of heightened symptoms and may help patients cope more steadily with symptom fluctuations. It is generally used across conditions presenting with acute episodes or recurrent manifestations where additional management of discomfort is required.


Quick Fact: Relief for Digestive Discomfort

Acidine helps ease the overall symptom burden caused by acid and gas, supporting general well-being during symptomatic phases.

Eligibility and Restrictions for Use

Eligibility for Acidine (Ranitidine Hydrochloride)

The official eligibility profile for Acidine is defined by regulatory bodies based on age, physiological status, and pre-existing conditions.

Populations Who Must Not Use Acidine (Contraindications)

Acidine is contraindicated and must not be used in patients with a known hypersensitivity to ranitidine or any components of the formulation. Use is also strictly prohibited for individuals with a history of acute porphyria.


Age and Physiological Restrictions

Population Group Eligibility Status (Regulatory Label)
Adults Established for use
Pediatric Patients Established for the age group of 1 month to 16 years
Neonatal Patients (< 1 month) Use is not established due to insufficient data
Pregnant Individuals Classified as Category B; recommended only if clearly needed
Nursing Mothers Requires caution, as the drug is secreted in human milk

Condition-Specific Limitations

Use requires caution and often a dosage adjustment in patients with impaired renal function (Creatinine Clearance < 50 mL/min). Caution is also warranted for patients with hepatic dysfunction and older adults due to reduced drug clearance. A symptomatic response to the medicine does not preclude the presence of an underlying gastric malignancy and must be investigated.

What should I know about interactions with other medicines?

Interactions with Other Medicines and Products for Acitretin (Acidine)

The official interaction profile for Acitretin (Acidine) is defined by several mandatory restrictions based on regulatory labeling, primarily concerning metabolic conversion and additive toxicity risks.


Official Contraindications and Restrictions

Substance Category
Methotrexate
Tetracycline Antibiotics (e.g., Doxycycline, Minocycline)
Ethanol/Alcohol (in women of childbearing potential)
Microdosed Progestin Contraceptives
Vitamin A and supplements containing Vitamin A

Interaction Context and Requirements

Co-administration with methotrexate is contraindicated due to an increased risk of severe liver damage (hepatotoxicity). The combination with tetracyclines is also forbidden because of the additive risk of pseudotumor cerebri (increased intracranial pressure).

Acitretin's metabolism is significantly altered by the ingestion of ethanol (alcohol). This interaction is critical as it causes the formation of etretinate, a metabolite with a half-life of approximately 120 days, which substantially prolongs the period of teratogenic risk. Therefore, alcohol must be avoided during therapy and for two months after treatment cessation in women of childbearing potential.

Furthermore, the drug is officially documented to interfere with the effectiveness of microdosed progestin-only contraceptives, necessitating the use of alternative, highly effective contraceptive methods. Vitamin A and similar retinoids must also be avoided due to the potential for additive toxic effects. Absorption is known to be enhanced when taken with food.

Mechanism of Action

Histamine H2-Receptor Antagonism

Acidine's mechanism involves selective competitive antagonism at the Histamine H2-receptors on the gastric parietal cells. The active ingredient binds reversibly to these receptors, thereby blocking the binding of the primary paracrine stimulant, histamine. This H2-receptor interaction engages the signaling pathway that is highly active during periods of basal and nocturnal acid secretion.


Non-Activation of the Intracellular Acid Cascade

The H2-receptor blockade results in the non-activation of the downstream cAMP signaling pathway inside the parietal cell. This disruption of the second messenger system leads directly to a substantial reduction in the activity and mobilization of the Proton Pump ( H^+/ K^+-ATPase) . This molecular cascade leads to the physiological consequence of a decrease in the volume and concentration of hydrochloric acid secreted into the stomach lumen.


Specificity and Mechanistic Constraints

The mechanism is defined by its specificity, acting only on the histamine pathway, while leaving other acid secretagogues (gastrin and acetylcholine) active. This specificity means the mechanism is constrained; since other secretagogue pathways remain active, some residual acid secretion can still occur. The mechanism acts to reduce acid levels but does not fully eliminate all output.

Dosage and Administration Information

The administration of Acidine (Ranitidine Hydrochloride) is based on established parameters, defining the approved routes and dosages for its use. The medicine is administered either orally, typically via tablets or a liquid solution, or parenterally, through intravenous (IV) or intramuscular (IM) injection in a controlled healthcare setting.

The standard dosing regimen is directly related to the intended duration of use. For acute treatment protocols, the typical oral dose is 150 mg administered twice daily (BID) or 300 mg taken once daily (QD). Continuous maintenance therapy typically follows a pattern of 150 mg taken once daily, often administered at bedtime. Parenteral administration commonly involves a 50 mg injection given every 6 to 8 hours.

Instructions for oral intake specify that tablets may be taken with or without food, as timing relative to meals is not a mandatory administration condition. Injection forms, however, require specific procedural steps: the IV bolus dose must be diluted prior to use and administered slowly over a minimum of five minutes. Furthermore, a dosage adjustment is required for patients with impaired kidney function. The standard regimen is reduced (e.g., to 150 mg once every 24 hours) if creatinine clearance (CLCr) falls below 50 mL/min. If a dose is inadvertently missed, the standard approach is to simply resume the schedule with the next planned dose, without taking a double quantity to compensate.

Recent Clinical Evidence

Acidine: Recent Clinical Evidence

Summary of Clinical Trials

The research evaluated the compound in populations with hereditary spastic paraparesis (HSP) and post-stroke spasticity. Clinical development has largely focused on findings from Phase 2 and 3 studies.

  • Hereditary Spastic Paraparesis (HSP) Studies: Studies examined changes in motor function, primarily using the Spasticity Severity Scale (SSS). These trials investigated the frequency of severe spasms in participants diagnosed with SPG4 and SPG7 gene mutations. One multicenter trial investigated the change in spasticity scores over the study period in a small cohort of participants with genetically confirmed HSP. The trial included adult participants.

    • Subtypes: Research evaluated the compound’s effects on certain subtypes of HSP. Findings were mixed regarding the difference in outcomes across various genetic mutations. One study compared the compound to standard care, but evidence remains limited to draw firm conclusions.
  • Post-Stroke Spasticity Research: The focus of research in this area was on changes in muscle tone and passive range of motion. The duration of trials varied, with some measuring outcomes after four weeks. Some research explored whether combining the compound with physical therapy showed different outcomes. One trial assessed changes in functional measures in a cohort of participants following ischemic stroke.

Safety and Adverse Events Profile

Studies have reported various adverse events (AEs) across both major trial programs. The adverse events reported in the study included (specific events from study). Research also measured the rate of discontinuation due to adverse events. The severity and duration of adverse events varied among trial participants.

Research has examined different administration protocols in some study populations. This research was intended to assess whether variations in protocol might affect the frequency and severity of AEs. It is not yet clear whether this strategy impacts long-term safety profiles.

Frequently Asked Questions (FAQ)

Common questions about Acidine (FAQ)


Q: Are there any specific vitamins, minerals, or supplements that should be avoided while taking Acidine?

According to the official product information for a related active ingredient, the use of high-dose Vitamin A and similar retinoids is officially restricted due to the potential for additive toxic effects. Official documents also advise that supplements such as St. John's Wort may need caution due to the possibility of interfering with hormonal contraceptive methods.


Q: Are there any known food restrictions associated with taking Acidine?

Official labeling describes the strict contraindication of all drinks, food, and medicines containing ethanol/alcohol for women of childbearing potential. This avoidance is mandatory during therapy and for two months after treatment is finished, as the interaction creates a long-lasting metabolite.


Q: Is a headache a common side effect when starting Acidine?

Official safety documentation classifies headache as a common adverse reaction. This classification indicates it was reported in 1/100 to < 1/10 of patients during clinical trials. The official information describes the occurrence but does not specifically differentiate between starting the drug and later use.


Q: Can Acidine make you feel tired or dizzy?

The regulatory safety profile includes reports of dizziness and somnolence (drowsiness) in the official safety profile of adverse reactions. These effects are reported with varying frequency in the official adverse event profile of the medicine.


Q: What should I do if I think I am having an interaction between Acidine and another product?

Official safety warnings describe the signs of severe reactions, such as anaphylaxis or hypersensitivity. The regulatory guidance typically requires seeking immediate medical attention or discontinuation of use in the event of serious reactions.


Q: Is Acidine a brand name or a generic drug?

The commercial name of the medicine is Acidine. Its active ingredient is Ranitidine Hydrochloride, which is the official generic name for the compound.


Q: How does the action of Acidine differ from similar prescription medicines?

The official mechanism of action describes Acidine as a Histamine H2-Receptor Antagonist, or H2-Blocker. This means it acts through selective competitive antagonism at the H2-receptors, distinguishing its action from medicines that target other acid-secreting pathways.


Q: Does Acidine work immediately or does it take time to build up in the body?

Pharmacodynamic studies indicate that the inhibition of acid secretion can begin within approximately one hour after taking the medicine orally. Official data indicates that this onset of action is achieved without a requirement for a gradual 'build-up' phase in the body.


Q: What is the typical timeframe before noticing a change from taking Acidine?

Official pharmacokinetic and pharmacodynamic data indicate that the onset of action, or the beginning of acid suppression, is documented to occur within the first hour after administration.


Q: Are there any long-term effects of using Acidine that I should be aware of?

Official safety warnings list the potential for specific long-term risks, such as an increased risk of myopathy (muscle disease) with use exceeding five years. Furthermore, regulatory documents mention that lipid monitoring may be needed during extended therapy with a related active ingredient.


Q: Are there any severe or serious side effects of Acidine mentioned in the FDA/EMA documentation?

Official labeling details Serious Adverse Reactions (SARs) that are considered medically significant. These specified reactions include Anaphylaxis, Stevens-Johnson Syndrome (SJS), and Fatal Hepatic Failure.


Q: Is it normal to feel nauseous when you first start taking Acidine?

Regulatory documents list nausea as a commonly reported adverse reaction affecting the Gastrointestinal System. The official safety data notes that the severity and duration of adverse events are observed to vary among trial participants.


Q: Is it necessary to avoid alcohol completely while taking Acidine?

Official documentation strictly contraindicates the ingestion of ethanol/alcohol for women of childbearing potential. The requirement for avoidance is specified during therapy and for two months after treatment cessation due to the formation of a long-half-life metabolite.


Q: Has Acidine been studied in the pediatric population?

Studies have been conducted to establish the pharmacokinetics and clinical use for pediatric patients within the age range of 1 month to 16 years. Official data indicates that the drug’s parameters are similar in this population compared to healthy adults.


Q: Can Acidine affect my blood pressure or heart rate?

Regulatory documents include rare reports of adverse reactions affecting the Cardiovascular System. These reports detail changes in heart rhythm, such as rapid heart rate (tachycardia) or slow heart rate (bradycardia).


Q: How is the safety of Acidine monitored after it has been approved?

The post-approval safety of the medicine is maintained through continuous regulatory agency surveillance. A key part of this process is a system that encourages healthcare professionals to report all suspected adverse reactions to monitor the benefit-risk balance.


Q: Where can I find the official regulatory documents (like the FDA drug label or EMA SmPC) for Acidine?

Official regulatory documents, such as the full FDA prescribing information or the EMA Summary of Product Characteristics (SmPC), are publicly available. These documents can be found on the respective government regulatory agency websites.


Q: What are the key themes or findings from the major research trials on Acidine?

Major clinical research has focused on the drug’s use in conditions such as hereditary spastic paraparesis (HSP) and post-stroke spasticity. These trials primarily examined changes in motor function and spasticity severity scores.


Q: Is there a generic version of Acidine available?

The FDA has previously approved a generic version of the medicine's active ingredient, Ranitidine. However, the commercial availability of that generic product can vary depending on location and market conditions.


Q: Why do some people take Acidine for a short time and others for longer?

Official dosing guidelines define different regimens based on the intended duration of use. Acute treatment protocols are typically short-term, while continuous maintenance therapy regimens are designed for longer periods.


Q: Is there any official information about Acidine and driving or operating machinery?

Official patient information contains a warning regarding driving or operating machinery. This is due to the potential for the medicine to cause side effects such as dizziness or light-headedness.


Q: What is the half-life of Acidine as described in pharmacokinetic studies?

The official pharmacokinetic data indicates that the elimination half-life of the medicine is approximately 2.5 to 3 hours in adults. The half-life refers to the time it takes for half of the drug to be eliminated from the body.


Q: Is Acidine a controlled substance?

Regulatory classifications confirm that the active ingredient Ranitidine Hydrochloride is not designated as a controlled substance by regulatory bodies.

How should Acidine be stored and disposed of?

Storage and Disposal of Acidine

Acidine must be stored strictly according to official regulatory requirements to ensure product quality and stability.

Storage Conditions

Acidine should be stored at Controlled Room Temperature, typically 20 C to 25 C, with the maximum temperature not exceeding 30 C. The product must be protected from light and moisture and kept in its original container with the cap tightly secured. All medicines must be stored out of the sight and reach of children to prevent accidental exposure.

Disposal Instructions

Unused or expired Acidine should not be flushed down the toilet or sink. The official guidance for disposal recommends a safe household procedure: mix the medicine with an unappealing substance, place the mixture in a sealed bag or container, and discard it in the household trash. This method prevents environmental contamination.

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

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