carospir
Carospir (Spironolactone) is an aldosterone antagonist used to treat Ascites, Edema, Heart Failure, Hirsutism.
Spironolactone · by Cmp Dev LLC
Available as a generic: Spironolactone
Key facts
- Active ingredient
- Spironolactone
- Drug class
- Aldosterone Antagonist
- Form
- Suspension
- Strength
- Spironolactone 25MG/5ML
- Type
- Prescription (Rx)
- Brand or generic
- Brand-name
- May treat
- ascites, edema, heart failure
- Manufacturer
- Cmp Dev LLC
- Half-life
- about 1.4 hours (how long it stays in your system)
- What the pharmacy pays
- ~$2.68 for 30 — not your price
- FDA application
- NDA209478
What is Carospir?
From the FDA label:Spironolactone Oral Suspension contains 25 mg of the aldosterone antagonist spironolactone, 17-hydroxy-7α-mercapto-3-oxo-17α-pregn-4-ene-21- carboxylic acid γ-lactone acetate per 5 mL, which has the following structural formula: Spironolactone is practically insoluble in water, soluble in alcohol, and freely soluble in benzene and in chloroform. Inactive ingredients include sorbic acid, potassium sorbate, citric acid anhydrous, sodium citrate dihydrate, simethicone emulsion, saccharin sodium, xanthan gum, Magnasweet 110, glycerin, banana flavor, and purified water. Chemical Structure
How to use
Spironolactone oral suspension is not therapeutically equivalent to Aldactone ( 2.1 ) Heart Failure: Initiate treatment at 20 mg once daily. ( 2.2 ) Hypertension: Initiate treatment at 20 to 75 mg daily in either single or divided doses ( 2.3 ) Edema associated with Hepatic Cirrhosis: Initiate therapy in a hospital setting and titrate slowly. The initial recommended daily dose is 75 mg in either single or divided doses ( 2.4 ) 2.1 General Considerations Spironolactone oral suspension is not therapeutically equivalent to Aldactone. Follow dosing instructions given here. In patients requiring a dose greater than 100 mg, use another formulation. Doses of the suspension greater than 100 mg may result in spironolactone concentrations higher than expected [see Clinical Pharmacology ( 12.3 )] . Spironolactone oral suspension can be taken with or without food, but should be taken consistently with respect to food [see Clinical Pharmacology ( 12.3 )] . 2.2 Treatment of Heart Failure In patients with serum potassium ≤5.0 mEq/L and eGFR >50 mL/min/1.73m 2 , initiate treatment at 20 mg (4 mL) once daily. Patients who tolerate 20 mg (4 mL) once daily may have their dosage increased to 37.5 mg (7.5 mL) once daily as clinically indicated. Patients who develop hyperkalemia on 20 mg (4 mL) once daily may have their dosage reduced to 20 mg (4 mL) every other day [see Warnings and Precautions (…
Side effects
The following clinically significant adverse reactions are described elsewhere in the labeling: Hyperkalemia [see Warnings and Precautions ( 5.1 )] Hypotension and Worsening Renal Function [see Warnings and Precautions ( 5.2 )] Electrolyte and Metabolic Abnormalities [see Warnings and Precautions ( 5.3 )] Gynecomastia [see Warnings and Precautions ( 5.4 )] Impaired neurological function/ coma in patients with hepatic impairment, cirrhosis and ascites [see Use in Specific Populations ( 8.7 )] The following adverse reactions associated with the use of spironolactone were identified in clinical trials or postmarketing reports. Because these reactions were reported voluntarily from a population of uncertain size, it is not always possible to estimate their frequency, reliably, or to establish a causal relationship to drug exposure. Digestive: Gastric bleeding, ulceration, gastritis, diarrhea and cramping, nausea, vomiting. Reproductive: Gynecomastia [see Warnings and Precautions ( 5.4 )] , decreased libido, inability to achieve or maintain erection, irregular menses or amenorrhea, postmenopausal bleeding, breast and nipple pain. Hematologic: Leukopenia (including agranulocytosis), thrombocytopenia. Hypersensitivity: Fever, urticaria, maculopapular or erythematous cutaneous eruptions, anaphylactic reactions, vasculitis. Metabolism: Hyperkalemia, electrolyte disturbances [see…
Warnings
Important safety information
Hyperkalemia: Monitor serum potassium within one week of initiation and regularly thereafter ( 5.1 ) Hypotension and Worsening Renal Function: Monitor volume status and renal function periodically ( 5.2 ) Electrolyte and Metabolic Abnormalities: Monitor serum electrolytes, uric acid and blood glucose periodically ( 5.3 ) Gynecomastia: Spironolactone oral suspension can cause gynecomastia ( 5.4 ) 5.1 Hyperkalemia Spironolactone oral suspension can cause hyperkalemia. This risk is increased by impaired renal function or concomitant potassium supplementation, potassium-containing salt substitutes or drugs that increase potassium, such as angiotensin converting enzyme inhibitors and angiotensin receptor blockers [see Drug Interactions ( 7.1 )] . Monitor serum potassium within 1 week of initiation or titration of spironolactone oral suspension and regularly thereafter. Closer monitoring may be needed when spironolactone oral suspension is given with other drugs that cause hyperkalemia or in patients with impaired renal function. If hyperkalemia occurs, decrease the dose or discontinue spironolactone oral suspension and treat hyperkalemia. 5.2 Hypotension and Worsening Renal Function Excessive diuresis may cause symptomatic dehydration, hypotension and worsening renal function, particularly in salt-depleted patients or those taking angiotensin converting enzyme inhibitors and angiotensin II receptor blockers. Worsening of renal function can also occur with concomitant use of nephrotoxic drugs (e.g., aminoglycosides, cisplatin, and NSAIDs). Monitor volume status and renal function periodically. 5.3 Electrolyte and Metabolic Abnormalities In addition to causing hyperkalemia, spironolactone oral suspension can cause hyponatremia, hypomagnesemia, hypocalcemia, hypochloremic alkalosis, and hyperglycemia. Asymptomatic hyperuricemia can occur and rarely gout is precipitated. Monitor serum electrolytes, uric acid and blood glucose periodically. 5.4 Gynecomastia Spironolactone oral suspension can cause gynecomastia. In RALES, patients with heart failure treated with a mean dose of 26 mg of spironolactone once daily, about 9% of the male subjects developed gynecomastia. The risk of gynecomastia increases in a dose-dependent manner with an onset that varies widely from 1-2 months to over a year. Gynecomastia is usually reversible.
Who should not take Carospir
Spironolactone oral suspension is contraindicated for patients with the following conditions: Hyperkalemia Addison’s disease Concomitant use of eplerenone Spironolactone oral suspension is contraindicated in patients with ( 4 ): Hyperkalemia Addison’s disease Concomitant use of eplerenone
Overdose — what happens if you take too much
The oral LD50 of spironolactone is greater than 1000 mg/kg in mice, rats, and rabbits. Acute overdosage of spironolactone oral suspension may be manifested by drowsiness, mental confusion, maculopapular or erythematous rash, nausea, vomiting, dizziness, or diarrhea. Rarely, instances of hyponatremia, hyperkalemia, or hepatic coma may occur in patients with severe liver disease, but these are unlikely due to acute overdosage. Hyperkalemia may occur, especially in patients with impaired renal function. Treatment: Induce vomiting or evacuate the stomach by lavage. There is no specific antidote. Treatment is supportive to maintain hydration, electrolyte balance, and vital functions. Patients who have renal impairment may develop hyperkalemia. In such cases, discontinue spironolactone oral suspension.
U.S. Poison Control: call or text 1-800-222-1222 (free, 24/7). In an emergency call 911. From the FDA label; not medical advice.
Interactions
Agents increasing serum potassium: Concomitant administration can lead to hyperkalemia ( 5.1 , 7.1 ) Lithium: Increased risk of lithium toxicity ( 7.2 ) NSAIDs: May reduce the diuretic, natriuretic and antihypertensive effect of spironolactone oral suspension ( 7.3 ) Digoxin: Spironolactone oral suspension can interfere with radioimmunologic assays of digoxin exposure ( 7.4 ) Cholestyramine: Hyperkalemic metabolic acidosis has been reported with concomitant use ( 7.5 ) Acetylsalicylic Acid (ASA): ASA may reduce the efficacy of spironolactone ( 7.6 ) 7.1 Drugs and Supplements Increasing Serum Potassium Concomitant administration of spironolactone oral suspension with potassium supplementation or drugs that can increase potassium may lead to severe hyperkalemia. In general, discontinue potassium supplementation in heart failure patients who start spironolactone oral suspension [see Warnings and Precautions ( 5.1 ) and Clinical Pharmacology ( 12.3 )] . Check serum potassium levels when ACE inhibitor or ARB therapy is altered in patients receiving spironolactone oral suspension. Examples of drugs that can increase potassium include: ACE inhibitors angiotensin receptor blockers aldosterone blockers non-steroidal anti-inflammatory drugs (NSAIDs) heparin and low molecular weight heparin trimethoprim 7.2 Lithium Like other diuretics, spironolactone oral suspension reduces the renal clearance of lithium, thus increasing the risk of lithium toxicity. Monitor lithium levels periodically when spironolactone oral suspension is coadministered [see Clinical Pharmacology ( 12.3 )] . 7.3 Nonsteroidal Anti-inflammatory Drugs (NSAIDs) In some patients, the administration of an NSAID can reduce the diuretic, natriuretic, and antihypertensive effect of loop, potassium-sparing, and thiazide diuretics. Therefore, when spironolactone oral suspension and NSAIDs are used concomitantly, monitor closely to determine if the desired effect of the diuretic is obtained [see Clinical Pharmacology ( 12.3 )] . 7.4 Digoxin Spironolactone and its metabolites increase the apparent exposure to digoxin. In patients taking concomitant digoxin, measure serum digoxin concentrations before initiating spironolactone using an assay that does not interact with spironolactone. Reduce digoxin concentrations by decreasing the dose by approximately 15-30% or by modifying the dosing frequency and continue monitoring [see Clinical Pharmacology ( 12.3 )] . 7.5 Cholestyramine Hyperkalemic metabolic acidosis has been reported in patients given spironolactone concurrently with cholestyramine. 7.6 Acetylsalicylic Acid Acetylsalicylic acid may reduce the efficacy of spironolactone. Therefore, when spironolactone oral suspension and acetylsalicylic acid are used concomitantly, spironolactone oral suspension may need to be titrated to higher maintenance dose and the patient should be observed closely to determine if the desired effect is obtained [see Clinical Pharmacology ( 12.3 )] . 7.7 CYP2C8 and CYP3A Substrates Spironolactone is an irreversible inhibitor for CYP2C8 and CYP3A4/5 in vitro [see Clinical Pharmacology ( 12.3 )] . Therefore, spironolactone may increase the exposure of other coadministered drugs that are metabolized by CYP2C8 and CYP3A4/5. Dosage adjustments of the drugs metabolized by CYP2C8 (e.g., repaglinide) and CYP3A4/5 (e.g., midazolam, sirolimus and tacrolimus) may be necessary if they are given concurrently with spironolactone.
How long does Spironolactone stay in your body?
The elimination half-life of spironolactone is about 1.4 hours — the time it takes the body to clear about half of it. As a rule of thumb, a medicine is mostly gone after roughly 4 to 5 half-lives, though this varies from person to person with age and kidney or liver function. The parent drug clears fast, but that number is misleading on its own: spironolactone is rapidly and extensively metabolized (mainly by CYP3A4/5, less by CYP2C8) into active metabolites that far outlast it. Canrenone has a mean half-life of 16.5 hours, 7-alpha-(thiomethyl)spirolactone (TMS) 13.8 hours, and 6-beta-hydroxy-7-alpha-(thiomethyl)spirolactone (HTMS) 15 hours — these metabolites are themselves aldosterone antagonists, so the drug's effect persists long after the parent is gone. The Aldactone label states the impact of age, sex, race/ethnicity, and renal impairment on spironolactone pharmacokinetics has NOT been specifically studied, so no labeled numbers exist for older adults or kidney impairment. In hepatic impairment the label does report that the terminal half-life is increased in patients with cirrhotic ascites, without giving a figure. There is no extended-release spironolactone in the US; the one alternative formulation, CaroSpir oral suspension, is immediate-release and lists a similar parent half-life of roughly 1 to 2 hours with metabolite half-lives of 10 to 35 hours, though it is not interchangeable with tablets (15-37% higher serum concentration at an equivalent dose). Food roughly doubles absorption (AUC up about 90-95%), which is why intake should be kept consistent relative to meals.
This is general information, not medical advice. It doesn’t tell you when a drug test would read negative (tests detect substances for different, often longer, windows) or when it’s safe to take another dose — ask your pharmacist or prescriber. Source: ALDACTONE (spironolactone) tablets, USP — FDA prescribing information, Section 12.3 Pharmacokinetics (Pfizer).
Drug class
May treat (source: NIH RxClass)
See how Carospir ranks — best-rated aldosterone antagonist for:
Dosage forms
Suspension
The forms currently marketed in the U.S., per the FDA National Drug Code Directory.
Ways to save
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Frequently asked questions
- What does Carospir treat?
- Carospir (Spironolactone) may be used to treat ascites, edema, heart failure, hirsutism, hyperaldosteronism, hypertension, based on NIH RxClass drug-classification data (conditions a drug may treat — not a verbatim copy of the FDA-approved label). This is general reference, not medical advice.
- How much does Carospir cost?
- Nobody can tell you what you will pay — your price is set by your insurer's formulary, your deductible and the pharmacy's markup, and none of those are published. What IS published is what the pharmacy paid to acquire it: about $2.68 for 30, per the CMS NADAC survey. Treat that as the floor, not the quote — ask the pharmacist for the cash price as well as your copay, because for cheap generics the cash price often wins.
- Is there a coupon or discount for Carospir?
- pharmaranks is an independent ratings site, not a pharmacy — we don't issue coupons or sell Carospir. To pay less, ask your prescriber or pharmacist whether a generic equivalent exists, check the manufacturer's copay/savings card and patient-assistance program, and compare a pharmacy discount card against your insurance copay. Prices vary by pharmacy, insurance, and location, so always confirm at the counter. This is general reference, not medical or financial advice.
- Who makes Carospir?
- Carospir is marketed by Cmp Dev LLC. You can see Cmp Dev LLC's full profile, rating, and other products on pharmaranks.
- Is Carospir a brand-name or generic drug?
- Carospir is a brand-name product with the active ingredient Spironolactone. Lower-cost generic equivalents containing Spironolactone are available — ask your pharmacist.
- Is Carospir available over the counter?
- No. Carospir is a prescription (Rx) medication in the US — you need a prescription from a licensed clinician (in person or via telehealth); it isn't sold over the counter. For some conditions there are OTC alternatives — ask your pharmacist.
- What forms does Carospir come in?
- Carospir is currently marketed as suspension, per the FDA's National Drug Code Directory.
- What class of drug is Carospir?
- Carospir is classified as aldosterone antagonist, per the FDA's Established Pharmacologic Class.
- Is Carospir FDA-registered?
- Carospir is on record with the U.S. FDA under application number NDA209478. You can verify this on its official FDA label.
- Is Carospir safe?
- There's no single safe-or-not verdict, and we don't yet have a composite recall-safety score for Carospir. Review its FDA-label side effects and warnings below, and always consult a licensed professional.
- What are the side effects of Carospir?
- Carospir's side effects are taken directly from its FDA label. From the label: The following clinically significant adverse reactions are described elsewhere in the labeling: Hyperkalemia [see Warnings and Precautions ( 5.1 )] Hypotension and Worsening Renal Function [see Warnings and Precautions ( 5.2 )] Electrolyte and Metabolic Abnormalities [see Warnings and Precautions (… Both common and serious reactions are documented in full on this page. This is general reference from the FDA, not medical advice — always consult a professional.
Clinical content sourced from the FDA label via openFDA (U.S. FDA). View the FDA label on DailyMed → Provided for general reference only — not medical advice. Always consult a licensed professional and the current prescribing information.
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