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CaroSpir
Overview
What is CaroSpir?
CAROSPIR 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.
What does CaroSpir look like?
What are the available doses of CaroSpir?
Oral suspension, 25 mg/5 mL
What should I talk to my health care provider before I take CaroSpir?
How should I use CaroSpir?
CAROSPIR (spironolactone) is indicated in the management of:
CAROSPIR 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 .
CAROSPIR can be taken with or without food, but should be taken consistently with respect to food .
What interacts with CaroSpir?
Sorry No Records found
What are the warnings of CaroSpir?
Sorry No Records found
What are the precautions of CaroSpir?
Sorry No Records found
What are the side effects of CaroSpir?
Sorry No records found
What should I look out for while using CaroSpir?
CAROSPIR is contraindicated for patients with the following conditions:
What might happen if I take too much CaroSpir?
The oral LD50 of spironolactone is greater than 1000 mg/kg in mice, rats, and rabbits.
Acute overdosage of CAROSPIR 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 CAROSPIR.
How should I store and handle CaroSpir?
Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.] Manufactured and Distributed by: Carlsbad, CA 92008 Revised: 06/12CTI-12 Rev. C Re-Packaged By: Preferred Pharmaceuticals Inc.Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.] Manufactured and Distributed by: Carlsbad, CA 92008 Revised: 06/12CTI-12 Rev. C Re-Packaged By: Preferred Pharmaceuticals Inc.Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.] Manufactured and Distributed by: Carlsbad, CA 92008 Revised: 06/12CTI-12 Rev. C Re-Packaged By: Preferred Pharmaceuticals Inc.Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.] Manufactured and Distributed by: Carlsbad, CA 92008 Revised: 06/12CTI-12 Rev. C Re-Packaged By: Preferred Pharmaceuticals Inc.CAROSPIR (spironolactone) Oral Suspension 25 mg/5 mL is a white to off-white, opaque, banana-flavored suspension. It is available in a 118 mL bottle (NDC 46287-020-04) and a 473 mL bottle (NDC 46287-020-01).Store at 20° to 25°C (68° to 77°F). Excursions permitted to 15° to 30°C (59° to 86°F) . Shake well before use. Dispense in a tight container as defined in the USP.CAROSPIR (spironolactone) Oral Suspension 25 mg/5 mL is a white to off-white, opaque, banana-flavored suspension. It is available in a 118 mL bottle (NDC 46287-020-04) and a 473 mL bottle (NDC 46287-020-01).Store at 20° to 25°C (68° to 77°F). Excursions permitted to 15° to 30°C (59° to 86°F) . Shake well before use. Dispense in a tight container as defined in the USP.
Clinical Information
Chemical Structure
No Image foundClinical Pharmacology
Spironolactone and its active metabolites are specific pharmacologic antagonists of aldosterone, acting primarily through competitive binding of receptors at the aldosterone-dependent sodium-potassium exchange site in the distal convoluted renal tubule. Spironolactone causes increased amounts of sodium and water to be excreted, while potassium is retained. Spironolactone acts both as a diuretic and as an antihypertensive drug by this mechanism. It may be given alone or with other diuretic agents that act more proximally in the renal tubule.
Non-Clinical Toxicology
CAROSPIR is contraindicated for patients with the following conditions:Clonidine may potentiate the CNS-depressive effects of alcohol, barbiturates or other sedating drugs. If a patient receiving clonidine hydrochloride is also taking tricyclic antidepressants, the hypotensive effect of clonidine may be reduced, necessitating an increase in the clonidine dose. If a patient receiving clonidine is also taking neuroleptics, orthostatic regulation disturbances (e.g., orthostatic hypotension, dizziness, fatigue) may be induced or exacerbated.
Monitor heart rate in patients receiving clonidine concomitantly with agents known to affect sinus node function or AV nodal conduction, , digitalis, calcium channel blockers and beta-blockers. Sinus bradycardia resulting in hospitalization and pacemaker insertion has been reported in association with the use of clonidine concomitantly with diltiazem or verapamil.
Amitriptyline in combination with clonidine enhances the manifestation of corneal lesions in rats (see ).
Based on observations in patients in a state of alcoholic delirium it has been suggested that high intravenous doses of clonidine may increase the arrhythmogenic potential (QT- prolongation, ventricular fibrillation) of high intravenous doses of haloperidol. Causal relationship and relevance for clonidine oral tablets have not been established.
CAROSPIR 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 .
Closer monitoring may be needed when CAROSPIR is given with other drugs that cause hyperkalemia or in patients with impaired renal function.
If hyperkalemia occurs, decrease the dose or discontinue CAROSPIR and treat hyperkalemia.
The following clinically significant adverse reactions are described elsewhere in the labeling:
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 ], decreased libido, inability to achieve or maintain erection, irregular menses or amenorrhea, postmenopausal bleeding, breast nad nipple pain.
Hematologic: Leukopenia (including agranulocytosis), thrombocytopenia.
Hypersensitivity: Fever, urticaria, maculopapular or erythematous cutaneous eruptions, anaphylactic reactions, vasculitis.
Metabolism: Hyperkalemia, electrolyte disturbances , hyponatremia, hypovolemia.
Musculoskeletal: Leg cramps.
Nervous system /psychiatric: Lethargy, mental confusion, ataxia, dizziness, headache, drowsiness.
Liver / biliary: A very few cases of mixed cholestatic/hepatocellular toxicity, with one reported fatality, have been reported with spironolactone administration.
Renal: Renal dysfunction (including renal failure).
Skin: Stevens-Johnson Syndrome (SJS), toxic epidermal necrolysis (TEN), drug rash with eosinophilia and systemic symptoms (DRESS), alopecia, pruritis, chloasma.
Reference
This information is obtained from the National Institute of Health's Standard Packaging Label drug database.
"https://dailymed.nlm.nih.gov/dailymed/"
While we update our database periodically, we cannot guarantee it is always updated to the latest version.
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