Carace

Method of action: Agents Acting In The Renin-Angiotensin System, Antihypertensive, Diuretic, Hypotensive

Treatment option: Hypertension

Medically reviewed

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 Carace

Quick Facts

Property	Description
Active Ingredients	Lisinopril (ACE Inhibitor) and Hydrochlorothiazide (Thiazide Diuretic)
Form	Fixed-dose combination (FDC) tablet
Pharmacological Class	Antihypertensive agents (ACE inhibitor with diuretic)
General Purpose	Management of sustained high blood pressure (hypertension)
Origin	Synthetic drug (Prescription-only medicine)

What is Carace?

Defining Carace: A Fixed-Dose Combination Antihypertensive

Carace is a prescription-only medicine (POM) that is definitively identified as a synthetic drug and a fixed-dose combination (FDC) tablet intended for oral administration. The active ingredients are Lisinopril, an Angiotensin-Converting Enzyme (ACE) Inhibitor, and Hydrochlorothiazide (HCTZ), a Thiazide Diuretic. This specific combination is clinically recognized for achieving superior blood pressure control compared to either agent used alone.

This preparation belongs to the broad category of Antihypertensive agents. The fixed-dose nature is a key feature, simplifying the regimen by combining two necessary agents from distinct pharmacological classes into a single tablet for patient convenience.

Composition and General Therapeutic Purpose

The medicine's composition is based on the co-formulation of Lisinopril (often the dihydrate salt form) and Hydrochlorothiazide. Lisinopril acts by blocking the Renin-Angiotensin-Aldosterone System (RAAS), promoting vasodilation, while Hydrochlorothiazide promotes diuresis (fluid removal).

The primary purpose of Carace is to assist in the long-term management of sustained hypertension (high blood pressure). The strategy of combination therapy is utilized because simultaneously addressing the body's fluid balance and its vessel tension regulation (two factors contributing to high blood pressure) ensures a robust and comprehensive reduction in pressure, which is essential for maintaining cardiovascular health.

Regulatory References

What side effects are possible with Carace?

Possible side effects and safety information

The official safety information for this fixed-dose combination (lisinopril/hydrochlorothiazide) organizes potential adverse reactions according to frequency and the body system affected, reflecting standardized regulatory reporting.

Commonly documented adverse reactions include Nervous System effects such as dizziness and headache, as well as the occurrence of a persistent, non-productive cough. Other frequent effects involve fatigue or asthenia and orthostatic effects (light-headedness upon standing), which may be more likely during the initial days of therapy.

Classification	System-Organ Classes Involved
Common	Nervous System, Respiratory, Gastrointestinal, General Disorders
Uncommon	Metabolic, Cardiovascular, Dermatological, Psychiatric

Serious Adverse Reactions

The regulatory label highlights several serious safety concerns. Angioedema, a severe swelling of the face, tongue, and throat that can obstruct the airway, is a documented serious reaction, which may occur at any time during treatment. Fetal Toxicity is a major safety restriction noted with a Boxed Warning for use during the second and third trimesters of pregnancy. Other severe reactions include the potential for acute renal failure and hepatic failure.

Population-Specific and Use Restrictions

Safety statements note that Black patients may have a higher rate of Angioedema associated with the ACE inhibitor component. The drug is contraindicated for use in pregnant women, patients with a history of ACE inhibitor-related Angioedema, or those with Anuria (absence of urine production). The risk of Non-melanoma skin cancer is also noted, associated with the diuretic component and cumulative long-term exposure.

Overdose and Emergency Response

Overdose Scope (Lisinopril/Hydrochlorothiazide)

An overdose of this combination medication is officially documented to present primarily with the severe physiological effects of its two active components. The most critical clinical manifestations listed in regulatory documents include severe hypotension (extremely low blood pressure) and acute renal failure.

Overexposure to the diuretic component may lead to significant dehydration and severe electrolyte disturbances, such as hypokalemia (low potassium) or hyponatremia (low sodium). Other documented manifestations of overdose include neurological symptoms like drowsiness, confusion, and seizures, alongside gastrointestinal distress and vomiting.

Overdose Management and Emergency Action

Official regulatory information states that the treatment approach in an overdose scenario is strictly symptomatic and supportive, as no specific antidote is known. This management includes the mandated correction of dehydration and electrolyte imbalance, often requiring the use of intravenous normal saline to manage severe hypotension. The regulatory standard requires frequent monitoring of serum electrolytes and creatinine and very close patient observation.

For any suspected overdose, official guidance requires the immediate contact of a poison control center or a healthcare professional. Urgent emergency services must be called if symptoms include collapse, trouble breathing, or seizures, due to the documented life-threatening risks.

Therapeutic Uses of Carace

What Carace Treats: Main Uses and Benefits

This medication is applied in the long-term management of essential hypertension (primary high blood pressure), which is a chronic condition characterized by persistently elevated pressure levels. It is generally used for adult patients whose blood pressure has not been adequately brought down to target goals using a single antihypertensive agent alone. The therapeutic benefit supports the management of the elevated pressure in conditions marked by increased physiological stress. This combination is commonly used to address high blood pressure and is applied in contexts where additional management of discomfort or tension is relevant.

The combination is relevant for easing the overall burden of symptoms associated with prolonged, uncontrolled hypertension. Continuous management is relevant for easing symptoms linked to organ-specific functional stress caused by high pressure. The key therapeutic uses are the management of conditions characterized by periods of heightened symptoms and addressing symptoms that create noticeable physiological strain. This is relevant when supportive symptom management is appropriate and contributes to easing the overall symptom load.

The fixed-dose tablet is commonly used across conditions presenting with chronic maintenance and is applied in clinical settings that involve chronic management. This combination assists with maintaining functional stability and may help patients cope more steadily with symptom fluctuations related to the condition. This approach helps manage symptom clusters that may become intense or disruptive and is relevant when supportive symptom management is appropriate.

Quick Fact: Management of Physiological Strain

Property	Description
Primary Therapeutic Domain	Management of sustained essential hypertension
Symptom Categories Addressed	Helps address symptoms related to systemic imbalance and physiological strain
Use Context	Applied when monotherapy fails or is relevant for simplified chronic management
Patient Benefit Focus	Contributes to easing the overall symptom load and assists with maintaining functional stability

Regulatory References

MedlinePlus Drug Information

Eligibility and Restrictions for Use

Carace (Lisinopril/Hydrochlorothiazide) is officially permitted for use in adult patients with essential hypertension whose blood pressure is not adequately controlled by monotherapy. Regulatory documents define several strict population limitations and absolute contraindications for the medicine.

Contraindicated Populations

Use is absolutely prohibited in patients with:

A history of angioedema related to any Angiotensin-Converting Enzyme (ACE) inhibitor, or hereditary angioedema.
Anuria (inability to pass urine) or severe renal impairment (creatinine clearance <30 mL/min).
Hypersensitivity to any component or to sulfonamide-derived drugs.
Concomitant use with Aliskiren in patients with diabetes or concomitant use with a neprilysin inhibitor (e.g., Sacubitril/Valsartan).

Age and Physiological Status Restrictions

Population	Regulatory Status
Pediatric Patients	Safety and effectiveness not established for the combination product in those under 18 years old.
Pregnancy	Contraindicated in the second and third trimesters. Discontinuation is advised immediately upon detection of pregnancy.
Lactation	Use not recommended, as components are excreted into human milk.
Older Adults	Use permitted, but caution is advised due to a higher likelihood of age-related renal or hepatic impairment.

What should I know about interactions with other medicines?

Interactions with other medicines and products

The interaction profile for Carace, a fixed-dose combination of Lisinopril and Hydrochlorothiazide, is defined by specific restrictions and effects documented in regulatory prescribing information.

Official Regulatory Restrictions

Co-administration with Sacubitril/Valsartan is contraindicated, with regulators mandating that Carace must not be administered within 36 hours before or after taking Sacubitril/Valsartan. Additionally, the use of Carace with Aliskiren-containing products is contraindicated in patients with Diabetes Mellitus or established Renal Impairment.

Pharmacodynamic and Exposure Effects

Interactions with Potassium-Sparing Diuretics (e.g., Spironolactone) and Potassium Supplements/Salt Substitutes may result in Hyperkalemia (high serum potassium) due to the Lisinopril component. Concomitant use with Non-Steroidal Anti-Inflammatory Drugs (NSAIDs) may diminish the blood pressure-lowering effect and increase the risk of renal function deterioration. Other substances, such as Lithium, have been shown to experience reduced renal clearance, leading to a risk of toxicity. Co-administration with Cimetidine is documented to result in an approximately 60% increase in the systemic exposure ( AUC) of Lisinopril. Use with alcohol may increase the risk of orthostatic hypotension.

Population-Specific Notes

For elderly patients, official data indicate a significant increase in the systemic exposure ( AUC) of both Lisinopril and Hydrochlorothiazide compared to younger patients.

Mechanism of Action

Carace (Captopril) functions as a competitive inhibitor of the angiotensin-converting enzyme (ACE), also known as kininase II. This enzyme target is a zinc-dependent dipeptidyl carboxypeptidase expressed primarily on the luminal surface of vascular endothelial cells.

The molecular interaction involves the reversible, high-affinity binding of Captopril to the active site of ACE. Its sulfhydryl moiety chelates the zinc ion within the enzyme's active center, effectively blocking its catalytic function. This inhibition halts the enzymatic conversion of angiotensin I, a decapeptide, into the potent octapeptide vasoconstrictor, angiotensin II.

Simultaneously, the molecular pathway modification retards the degradation of bradykinin, a potent endogenous vasodilator. The intracellular consequence of reduced ACE activity is a significant decrease in circulating angiotensin II and a local accumulation of bradykinin. This leads to diminished stimulation of the angiotensin type 1 (AT1) receptor signaling pathway.

The system-level physiological consequence of this dual modulation is a sustained decrease in peripheral vascular resistance due to arteriolar and venous vasodilation, accompanied by reduced aldosterone secretion, which modulates volume and electrolyte balance.

Dosage and Administration Information

The official use of the medicine branded as Carace (most commonly referring to Fluorouracil topical cream, 0.5%) is strictly governed by the official instructions for administration.

Administration Protocol

Scope Element	Official Regulatory Instructions
Route of Administration	Topical use on the skin only. Use is not approved for ophthalmic, oral, or intravaginal application.
Standard Dosing	Apply a thin film to the entire affected area once daily (typically in the morning).
Course Duration	The medication is typically used for a maximum of 4 weeks (for actinic keratoses). Treatment must be discontinued earlier if erosion is excessive.
Preparation	The skin area should be washed thoroughly and dried completely for approximately 10 minutes before application.
Administration	The cream should be applied using the fingertips, a glove, or a nonmetal applicator. Hands must be washed immediately and thoroughly after application to prevent unintentional exposure.
Missed Dose	If a dose is missed, apply it as soon as it is remembered unless it is almost time for the next scheduled dose; in that case, the missed dose should be skipped.

Administration Constraints

Contact with the eyes, eyelids, nostrils, and mouth must be strictly avoided. The medication must only be used for the condition for which it was prescribed. It is not indicated for use in children.

These instructions establish a standardized routine for topical use, defining the exact frequency, application procedure, and time-bound nature of the therapy.

Recent Clinical Evidence

Research Evidence / Overview of Studies for Carace

Evidence for Use in Managing Essential Hypertension

Research has explored the use of the fixed-dose combination (FDC) of Lisinopril and Hydrochlorothiazide, primarily consisting of Randomized Controlled Trials (RCTs). These studies typically examined adult patients with mild-to-moderate high blood pressure. Trials monitored Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) measurements to evaluate blood pressure changes over time.

Findings describe patterns where co-administering the two components was associated with measured blood pressure changes that were approximately additive when compared to measurements observed with only one drug. Regulatory data suggest the measured blood pressure pattern was observed over 24 hours following a dose in most patients studied, consistent with once-daily dosing.

Research on Utility and Long-Term Outcomes

Bioequivalence Studies indicated that the FDC tablet delivered the active ingredients into the body in a way that was comparable to taking the two individual components separately. Observational studies also monitored adherence to therapy, finding that the use of FDCs was associated with patterns where patient adherence was observed to be higher compared to regimens requiring separate pills.

For long-term outcomes, the evidence remains limited specifically for the FDC's direct influence on major cardiovascular events (like heart attacks or strokes) over many years. While the effects of blood pressure reduction are generally studied in large trials involving the individual drug classes (ACE inhibitors and diuretics), the specific FDC's long-term effect on these hard clinical outcomes is not fully established by dedicated, multi-year trials.

Evidence in Specific Patient Populations and Gaps

Research has explored the medication's effects in different adult patient groups, including older adults, where patients may show higher levels of both components in their blood plasma. Subgroup analyses regarding race/ethnicity have been conducted. Some findings indicate that patterns of blood pressure response may be less evident for certain dose combinations in Black hypertensive patients compared to non-Black patients, but regulatory reports acknowledge that relatively few patients were included in some dose comparisons, meaning subgroup findings are uncertain.

Key uncertainties remain, including the lack of extensive, long-term data on cardiovascular event reduction specifically for the FDC, the inconsistency of subgroup findings, and the insufficient data for certain groups, such as the pediatric population.

Frequently Asked Questions (FAQ)

Common questions about Carace (FAQ)

Q: What is Carace?

A: Carace is a prescription medication available as a tablet that is indicated for the treatment of high blood pressure (hypertension). It is in a class of drugs known as ACE inhibitors.

Q: How does Carace work?

A: Carace is thought to influence the body's renin-angiotensin system, which plays a role in regulating blood pressure.

Q: What should I do if I miss a dose of Carace?

A: If you miss a dose of Carace, it is generally recommended to take it as soon as you remember. However, if it is close to the time for your next scheduled dose, skip the missed dose and return to your regular dosing schedule. This information is not clinical advice; always follow the directions provided by your prescriber.

Q: What are the common side effects of Carace?

A: The most commonly reported side effects in clinical trials include cough, dizziness, and fatigue. These side effects are typically mild and often decrease with continued use.

How should Carace be stored and disposed of?

How to Store and Dispose of Lisinopril/Hydrochlorothiazide (Carace)

Official Storage Requirements

The tablets must be stored at controlled room temperature, specifically between 20 C and 25 C (68 F and 77 F). It is essential to protect the medication from moisture and light; do not store the tablets in the bathroom or areas with excess heat. Keep the medication in its tightly closed, original container and always store it out of the sight and reach of children and pets.

Official Disposal Instructions

For unused or expired tablets, the preferred method of disposal is a medication take-back program. If this is unavailable, the product should be mixed with an unappealing substance, placed in a sealed bag, and discarded in the household trash. Before disposing of the empty container, scratch out all personal identifying information.

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

Available in countries:

United Kingdom

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