What is spironolactone FDA approved for?
Aldactone (spironolactone) is indicated in the management of: Primary hyperaldosteronism for: Establishing the diagnosis of primary hyperaldosteronism by therapeutic trial. Short-term preoperative treatment of patients with primary hyperaldosteronism.
What is Canrenone used for?
Canrenone is an antimineralocorticoid and active metabolite of spironolactone used in the treatment of primary hyperaldosteronism and edematous states caused by secondary hyperaldosteronism (e.g. heart failure). Canrenone has been used in trials studying the diagnostic of Heart Failure.
What is the black box warning for the Aldactone?
There is a black box warning for spironolactone stating that it may increase certain tumors, which has been shown in animal studies, but Dr. Graber notes that the dosage of medication was significantly higher than what is prescribed for women to treat acne.
What classification is spironolactone?
Spironolactone is in a class of medications called aldosterone receptor antagonists. It causes the kidneys to eliminate unneeded water and sodium from the body into the urine but reduces the loss of potassium from the body.
Is spironolactone FDA approved for acne?
In addition, spironolactone is not FDA approved for any skin-related conditions, even though it has been used to treat acne for over 30 years now.
Is Canrenone a steroid?
Canrenone, sold under the brand names Contaren, Luvion, Phanurane, and Spiroletan, is a steroidal antimineralocorticoid of the spirolactone group related to spironolactone which is used as a diuretic in Europe, including in Italy and Belgium.
Is spironolactone a carcinogen?
Overall, it concludes that ‘spironolactone is not classifiable as to its carcinogenicity to humans (Group 3)’ 4.
Why is spironolactone considered a hazardous drug?
2.3 Harmful if inhaled, swallowed, or in contact with skin. Material may be irritating to the mucous membranes and upper respiratory tract. May cause eye, skin, or respiratory system irritation. Suspected of causing cancer.
Is USP 800 mandatory?
No, USP 800 is a recommended standard for the safe handling of hazardous drugs. However, compliance surrounding how the Standard is executed is enforced by a variety of regulatory agencies from a local to federal level.
What are handling requirements for spironolactone?
If tablets or capsules are crushed and/or broken, avoid breathing dust and avoid contact with eyes, skin, and clothing. When handling, use appropriate personal protective equipment (see Section 8). Wash thoroughly after handling. Releases to the environment should be avoided.
When was Aldactone FDA approved?
Approval Date: 08/20/2001.
Why is canrenone banned?
Canrenone is not performance-enhancing but is banned because it is listed as a diuretic, which means it can be used to mask other banned substances.
Is spironolactone toxic?
Overdose. Spironolactone is relatively safe in acute overdose. Symptoms following an acute overdose of spironolactone may include drowsiness, confusion, maculopapular or erythematous rash, nausea, vomiting, dizziness, and diarrhea.