Claroft

Quick links to important sections

Claroft

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 Claroft

Quick Facts

Property Description
Active Ingredient Naphazoline Hydrochloride
Form Ophthalmic Solution (Eye Drops)
Pharmacological Class Ophthalmic Decongestant, Sympathomimetic Agent
General Purpose Reduction of eye redness and mild irritation
Origin Synthetic Compound (Imidazoline Derivative)

What Type of Medication is Claroft?

Claroft is classified as an Ophthalmic Decongestant and a Sympathomimetic Agent, delivered as an Ophthalmic Solution for strictly Topical Ocular administration. This classification identifies the drug's intended use as acting locally on the vascular system of the eye. The World Health Organization (WHO) Anatomical Therapeutic Chemical (ATC) classification system places naphazoline in the S01GA01 category for sympathomimetics used as decongestants in ophthalmology.

Composition: Naphazoline Hydrochloride and Ocular Form

The sole active component in Claroft is Naphazoline Hydrochloride, a synthetic substance belonging to the class of imidazoline derivatives. Claroft is a Monotherapy product, meaning it contains only this specific compound, formulated within an aqueous vehicle tailored for safe contact with the ocular surface. The structure of the active ingredient is engineered to specifically target the eye's vascular system, differentiating its action from simple lubricants.

How Does Claroft Produce its Effect?

The fundamental action of Claroft is based on the principle of vasoconstriction. Naphazoline Hydrochloride is a direct-acting sympathomimetic amine that stimulates the alpha-adrenergic receptors in the arterioles of the conjunctiva. This action causes the small blood vessels to constrict or narrow. The resulting physiological effect is ocular decongestion, which is the general purpose of the medicine: reducing the visible redness and alleviating the mild physical discomfort, for example, after prolonged exposure to environmental irritants or minor eye strain.

What side effects are possible with Claroft?

Possible side effects and safety information

Claroft (Naphazoline Ophthalmic Solution) is associated with an official safety profile that encompasses both local ocular effects and the potential for systemic reactions following absorption, as documented in government regulatory sources such as the FDA and EMA.

Adverse reaction scope

Key adverse reaction categories: The side effects are grouped into Eye Disorders and Systemic Disorders, reflecting the potential for local action and wider systemic effects of the sympathomimetic active ingredient.

Frequency classification: The most Common local effects listed in official documents are mydriasis (pupillary dilation), transient stinging, and eye irritation. Many systemic effects (e.g., headache, hypertension) are often reported in post-marketing surveillance and have a Not Known frequency.

System-organ classes involved: Effects are documented in Eye Disorders, Nervous System Disorders (e.g., dizziness, headache), Vascular Disorders (e.g., hypertension, cardiac irregularities), and Gastrointestinal Disorders (nausea).

Serious adverse reactions: Regulatory documents emphasize two critical, non-therapeutic risks:

  • Severe Systemic Toxicity: Accidental ingestion by infants and young children is documented to cause severe reactions, including Central Nervous System (CNS) depression, hypothermia, and coma [FDA Safety Communication].
  • Severe Hypertensive Crisis: This risk is explicitly documented when Naphazoline is used in conjunction with Monoamine Oxidase Inhibitors (MAOIs).

Population-specific safety considerations: Safety and effectiveness in the pediatric population have not been established. In pregnant and nursing individuals, use should be considered only if clearly needed, as it is unknown if the substance causes fetal harm or is excreted in human milk.

Dose- or exposure-related patterns: Rebound ocular hyperemia—the return or worsening of eye redness—is a documented consequence associated with prolonged or excessive use of the medication.

Safety classifications (high-level)

Regulatory basis: Safety findings are derived from official regulatory documents (FDA DailyMed and European SmPC). The profile includes cautions regarding the risk of increased Intraocular Pressure (IOP) in susceptible individuals due to mydriasis.

Resulting safety structure:

  • The official safety profile is defined by both common local effects and the potential for serious, systemic adverse events.
  • The highest safety constraint involves the documented risk of severe toxicity following accidental ingestion, particularly in young children.
  • The risk of rebound redness is a documented exposure-related pattern that restricts the duration of use.

Connection to the overall safety profile: The official safety information establishes that the medicine’s sympathomimetic action carries the documented potential for systemic effects like hypertension. This risk profile is critically framed by the severe, non-therapeutic toxicities associated with accidental ingestion and documented drug interactions, constraining its overall use.

Overdose and Emergency Response

The official regulatory profile for Claroft (Naphazoline Hydrochloride) overdose is defined by the risk of systemic toxicity following accidental ingestion of the topical solution. Government health authorities classify the resulting systemic absorption as a serious adverse reaction with severe life-threatening consequences. The documented manifestations include Central Nervous System (CNS) depression, presenting as somnolence, stupor, and potentially coma.

Physiological effects noted in regulatory documentation include marked hypothermia (reduction in body temperature), bradycardia (slowed heart rate), and hypotension (low blood pressure), often alongside decreased respiration (respiratory depression).

Infants and children (age five and younger) are explicitly identified as a highly vulnerable population, with ingestion of even a small amount (e.g., 1–2 mL) documented to cause these severe systemic events.

Regulators explicitly mandate that individuals seek emergency medical care immediately following any known or suspected accidental ingestion. It is required to call the Poison Help Line/Poison Control Center right away. Hospitalization and continuous symptomatic and supportive treatment and monitoring are necessary, as there is no specific antidote listed in the official prescribing information for managing this form of toxicity.

Therapeutic Uses of Claroft

The therapeutic utility of Claroft is generally focused on managing specific, non-pathological eye symptoms. The medication is considered relevant when supportive symptom management is appropriate for temporary issues.

What Claroft Treats: Main Uses and Benefits

Claroft is used to provide symptomatic support for ocular redness and associated mild sensory discomfort, primarily in conditions characterized by periods of heightened symptoms. The medication is commonly applied in scenarios where short-term symptomatic assistance is needed to ease symptoms related to physical discomfort, such as burning, scratchiness, or irritation. It is relevant across situations involving temporary exposure to external stressors, including wind, dust, air pollution, or transient eye strain from concentration.

The medication helps address symptom clusters that may become intense or disruptive, supporting general well-being during symptomatic phases. The medication is used in situations involving certain distressing symptoms, and is not for underlying disease treatment.

“The primary goal of use is to provide supportive relief when symptoms interfere with routine activities.”

Claroft is commonly used to help with the pronounced visible symptom burden, assists with supporting functional stability, and provides supportive relief when symptoms interfere with routine activities.


Quick Fact: Symptomatic Support for Ocular Redness & Minor Irritation

Regulatory References

  1. DailyMed overview of Naphazoline Hydrochloride uses

Eligibility and Restrictions for Use

Eligibility Map: Who Can and Cannot Use Claroft

The regulatory profile for Claroft (Naphazoline Hydrochloride) establishes clear criteria for eligibility based on official government labeling, defining both prohibitions and conditions for use.

Category Official Regulatory Statement
Allowed Populations Adults and children 6 years of age and older.
Not Recommended Children under 6 years of age. Official warnings cite the severe risk of Central Nervous System (CNS) depression, coma, and hypothermia in infants and young children.
Absolute Contraindications Patients with narrow-angle glaucoma or an anatomically narrow angle must not use the medicine. It is also forbidden for those with known hypersensitivity to any ingredient.
Drug-Treatment Ban Use is contraindicated in patients currently taking Monoamine Oxidase Inhibitors (MAOIs), due to the risk of a severe hypertensive crisis.
Conditional Use (Caution) Caution is required for patients with pre-existing conditions, including hypertension, cardiovascular abnormalities, hyperglycemia (diabetes), and hyperthyroidism.

Eligibility Status

  • Pregnancy and Lactation: Classified as Pregnancy Category C (use only if clearly needed). Caution must be exercised during lactation as excretion into human milk is unknown.
  • Data Status: Safety and effectiveness are officially not established for the overall pediatric population or the geriatric population.

What should I know about interactions with other medicines?

The official regulatory documentation for Claroft (Naphazoline Hydrochloride) structures the interaction profile around the risk of reinforcing the drug's systemic pressor effects. This profile is heavily concentrated on pharmacodynamic potentiation.

Contraindicated Combinations and Restrictions

A primary constraint detailed in the labeling concerns co-administration with Monoamine Oxidase Inhibitors (MAOIs). This combination is formally restricted because patients under MAOI therapy face the potential for a severe hypertensive crisis when exposed to a sympathomimetic agent like Naphazoline. This constitutes a severe, life-threatening interaction risk that prohibits concomitant use.

Documented Pharmacodynamic Potentiation

The regulatory label specifies that concurrent use of other antidepressant classes may also potentiate the pressor effect. Specifically, co-administration with Tricyclic Antidepressants (TCAs) and the related antidepressant Maprotiline is documented to increase the potential for this systemic response. This classification confirms the interaction mechanism as primarily pharmacodynamic.

Scope of Documentation

The official interaction statements do not include mandatory timing-based administration rules for other medicinal products. Furthermore, the regulatory documentation does not explicitly define formal interaction outcomes for food, alcohol, herbal products, or specific metabolic pathways such as CYP-mediated or transporter-based effects.

Mechanism of Action

How Claroft Works: Pharmacodynamic Mechanism

Claroft (Naphazoline Hydrochloride) acts by selectively engaging the local ocular sympathetic pathway to modulate vascular tone. The drug functions as a direct-acting agonist on alpha-1 adrenergic receptors (α1-ARs) located on the smooth muscle cells of the conjunctival arterioles. This molecular interaction initiates a Gq-protein coupled signaling cascade, which leads to an elevation of intracellular calcium ions ( Ca^2+).

The resultant increase in Ca^2+ is the molecular trigger for vascular smooth muscle contraction, a physiological process defined as vasoconstriction. This narrowing of the blood vessel lumen reduces the volume of blood flowing through the conjunctival vasculature, thereby diminishing blood flow within the local tissue.

This mechanism, however, is subject to tachyphylaxis (rapidly decreasing response) following prolonged exposure due to receptor desensitization. This functional constraint of the α1-AR system can lead to subsequent rebound hyperemia, which is a vascular overcompensation phenomenon occurring when the drug is withdrawn after chronic use.

Dosage and Administration Information

How to Use Claroft: Administration Instructions

Claroft is an ophthalmic suspension intended for topical use in the eye. The instructions for its use define a specific administration protocol, including the exact dosage, frequency, and time frame for application.

Dosing and Frequency

Instruction Category Requirement
Route of Administration Ophthalmic (Eye Drops)
Dosing Schedule Instill one drop into the affected eye(s)
Frequency Twice daily (BID)
Treatment Duration For the first 2 weeks post-operatively

Administration Procedure

Before each use, the bottle must be shaken well to ensure the medicine is properly mixed. Hands must be washed thoroughly prior to handling the bottle or administering the drops to maintain sterility. The eye drops should be instilled into the affected eye(s) as prescribed.

Treatment must strictly begin the day after surgery and must not exceed the 2-week post-operative period specified in the regimen. If using other topical eye medications concurrently, a required waiting time must be observed. A patient must wait at least 5 minutes between the administration of Claroft and any other eye drops to allow for proper absorption of each medication.

Handling Missed Doses

If a dose of Claroft is missed, patients should continue with the next scheduled dose. It is strictly instructed not to instill more than one drop to compensate for the missed application at the regularly scheduled time.

Recent Clinical Evidence

Research evidence / Overview of Studies for Claroft

Evidence for Use in Temporary Ocular Redness and Minor Irritation

The research evidence used to support the regulatory classification of Claroft is based on established pharmacological principles and several types of studies. The active ingredient, naphazoline, was studied in the context of its classification as a vasoconstrictor. Research in this area primarily involves short-term, randomized, comparative trials where the medicine was evaluated in healthy adult volunteers or those with mild, non-pathological redness.

These studies examined outcomes related to patient-reported discomfort and the visible appearance of the eye. Researchers measured changes in the level of Conjunctival Hyperemia (redness) using specific grading scales. The findings describe patterns observed in the studies, including measurements related to changes in visible redness after application. These findings help contextualize patterns observed in studies focusing on episodic or acute changes in eye appearance due to external factors like dust or wind.

Limitations of Long-Term Studies and Follow-up Data

A key limitation across the research landscape for Claroft is the limited information for long-term outcomes. The studies that exist are primarily focused on short, defined time intervals, and follow-up durations were limited. This means that the long-term effects are not fully established, particularly concerning daily use over extended periods.

Scientific literature also describes patterns related to the potential for the effect to diminish over time. More critically, research has explored the possibility of rebound hyperemia—where stopping the medicine may be associated with a return of redness that is more intense than the original symptom. The scientific literature describing this potential outcome was associated with strict limitations on the duration of use.

What Is Still Uncertain About Claroft's Research Profile

The overall evidence base highlights areas where data for long-term investigation remains limited. While short-term responses have been studied, the research is ongoing in a broader sense to fully characterize the consistency of the decongestive effect over weeks or months of repeated use.

The evidence quality varies across studies, and many findings are derived from acute, rather than chronic, observational settings. A lack of extensive comparative evidence with newer treatments is another area where research is limited. These factors mean that the certainty remains low for questions related to extended or continuous application of the medication.

Key Studies & References

  1. ALBALON® (naphazoline hydrochloride ophthalmic solution, USP) 0.1% - DailyMed Label

Frequently Asked Questions (FAQ)

Common questions about Claroft (FAQ)

Q: Can I take Claroft if I am on a Tricyclic Antidepressant?

A: Official regulatory documents specify that co-administration with Tricyclic Antidepressants (TCAs) is documented to increase the potential for a systemic pressor effect, meaning a rise in blood pressure. Patients who are taking a TCA are advised to discuss their medication regimen with a healthcare professional to assess whether Claroft is appropriate.

Q: What should I do if I accidentally get Claroft in my mouth?

A: Claroft is formulated for topical eye use only. According to official safety warnings, accidental ingestion—especially by infants and young children—can cause severe systemic toxicity, including Central Nervous System (CNS) depression and coma. In the event of accidental ingestion, immediate professional medical help or contact with a Poison Control Center is recommended due to this documented risk.

Q: Can Claroft be used for long-term eye redness?

A: Studies and official product information focus on short-term application. Prolonged or excessive use of Claroft is associated with the documented risk of 'rebound ocular hyperemia.' This is a pattern where the eye redness may return or worsen when the medication is stopped.

Q: Is it okay to wear contact lenses while using Claroft?

A: The official administration instructions for Claroft require that contact lenses be removed before the eye drops are applied. Specific timing for reinsertion is generally found within the product labeling, and patients should follow the detailed instructions provided with the medicine.

Q: Where can I take my old or expired Claroft for disposal?

A: Regulatory guidance states that the preferred disposal method for Claroft is using an authorized drug take-back program. The FDA advises that information on authorized drug disposal locations, such as DEA collectors or drug disposal kiosks, can be obtained from local pharmacies or law enforcement agencies.

How should Claroft be stored and disposed of?

Storage and Disposal of Claroft (Naphazoline Ophthalmic Solution)

Official Storage Conditions

Claroft must be stored at controlled room temperature, specifically between 15 C and 25 C (59 F and 77 F), in its original container with the cap tightly closed. The product must be protected from light and must not be frozen. To ensure child safety, the medicine should always be stored out of the sight and reach of children.

Condition Requirement
Temperature 15 C to 25 C (Do Not Freeze)
In-Use Limit Discard 28 days after opening
Protection Keep tightly closed; Protect from light

Disposal Requirements

Unused or expired Claroft must be disposed of according to local pharmaceutical waste requirements. Regulatory guidance specifies that the medicine must not be flushed down a toilet or poured down a drain to prevent environmental contamination. The preferred method for disposal is using an authorized drug take-back program.

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

Available in countries:

Equivalent of Claroft found in:

A-Z Index: