Cetoderm Side effects

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• Side effects of Cetoderm in details
• Cetoderm contraindications
• Cetoderm reviews

What are the possible side effects of Cetoderm?

Get emergency medical help if you have any signs of an allergic reaction to Cetoderm: hives; fever; difficulty breathing, chest pain; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have:

• headache with chest pain and severe dizziness, fainting, fast or pounding heartbeats;

• unusual weakness or tired feeling, nausea and vomiting; or

• liver problems--upper stomach pain, itching, tired feeling, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes);

Common Cetoderm side effects may include:

• mild nausea or stomach pain;

• diarrhea; or

• headache.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Side effects of Cetoderm in details

Topically applied Cetoderm appears to have a low order of toxicity and is generally well tolerated. Adverse effects have been reported in up to 5% of patients receiving Cetoderm 2% cream and have consisted principally of local reactions such as severe irritation, pruritus, and stinging. A painful allergic reaction, consisting of localized swelling and inflammation, occurred in at least one patient receiving Cetoderm 2% cream and contact dermatitis occurred in another.

In several studies evaluating the potential of topical Cetoderm for causing dermal irritation, contact sensitization, or phototoxic or photoallergenic reactions in healthy adults, topical application of Cetoderm 2% cream caused mild transient erythema in some individuals, but did not cause contact sensitization of the delayed hypersensitivity type, irritation, phototoxicity, or photocontact sensitization.

Contact dermatitis has been reported following topical application of imidazole-derivative azole antifungals (e.g., clotrimazole, econazole, miconazole, oxiconazole, sulconazole, tioconazole). Cross-sensitization appears to occur among the imidazole derivatives; however, cross-sensitivity appears to be unpredictable. The fact that patients with contact sensitivity to one imidazole-derivative azole antifungal may be sensitive to other similar drugs should be considered.

Although hepatotoxicity has occurred during treatment with oral Cetoderm, it is unlikely that this adverse effect would occur with Cetoderm 2% cream since the drug does not appear to be appreciably absorbed following topical application to skin.

Adverse effects reported in patients receiving topical Cetoderm 2% as a shampoo applied to the skin include pruritus, application site reaction, and dry skin. Adverse effects reported in patients receiving Cetoderm shampoo to the scalp include increased hair loss, irritation, abnormal hair texture, scalp pustules, dry skin, pruritus, and oiliness or dryness of the hair and scalp. In some patients with permanently waved (“permed”) hair, use of Cetoderm 2% shampoo resulted in loss of the curl.

What is the most important information I should know about Cetoderm?

• Cetoderm foam is for external use only. Do not get it in your eyes, nose, vagina, or mouth. If you get it in any of these areas, rinse at once with cool tap water.
• Do NOT use more than the recommended dose or use for longer than prescribed without checking with your doctor.
• If your symptoms do not get better within 4 weeks or if they get worse, check with your doctor.
• Do not use Cetoderm foam for other skin conditions at a later time.
• Talk with your doctor before you use any other medicines or cleansers on your skin.
• Cetoderm foam may cause you to become sunburned more easily. Avoid the sun, sunlamps, or tanning booths until you know how you react to Cetoderm foam. Use a sunscreen or wear protective clothing if you must be outside for more than a short time.
• Cetoderm foam is flammable. Do not store or use near an open flame. Do not smoke during or right after use of Cetoderm foam.
• Cetoderm foam should be used with extreme caution in CHILDREN younger than 12 years old; safety and effectiveness in these children have not been confirmed.
• PREGNANCY and BREAST-FEEDING: If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using Cetoderm foam while you are pregnant. It is not known if Cetoderm foam is found in breast milk after topical use. If you are or will be breast-feeding while you use Cetoderm foam, check with your doctor. Discuss any possible risks to your baby.

Cetoderm contraindications

Drug Interactions

Coadministration of a number of CYP3A4 substrates such as dofetilide, quinidine cisapride and pimozide is contraindicated with Cetoderm Tablets. Coadministration with Cetoderm can cause elevated plasma concentrations of these drugs and may increase or prolong both therapeutic and adverse effects to such an extent that a potentially serious adverse reaction may occur. For example, increased plasma concentrations of some of these drugs can lead to QT prolongation and sometimes resulting in life-threatening ventricular tachyarrhythmias including occurrences of torsade de pointes, a potentially fatal arrhythmia.

Additionally, the following other drugs are contraindicated with Cetoderm Tablets: methadone, disopyramide, dronedarone, ergot alkaloids such as dihydroergotamine, ergometrine, ergotamine, methylergometrine, irinotecan, lurasidone, oral midazolam, alprazolam, triazolam, felodipine, nisoldipine, ranolazine, tolvaptan, eplerenone, lovastatin, simvastatin and colchicine.

Enhanced Sedation

Coadministration of Cetoderm Tablets with oral midazolam, oral triazolam or alprazolam has resulted in elevated plasma concentrations of these drugs. This may potentiate and prolong hypnotic and sedative effects, especially with repeated dosing or chronic administration of these agents. Concomitant administration of Cetoderm Tablets with oral triazolam, oral midazolam or alprazolam is contraindicated.

Myopathy

Coadministration of CYP3A4 metabolized HMG-CoA reductase inhibitors such as simvastatin, and lovastatin is contraindicated with Cetoderm Tablets.

Ergotism

Concomitant administration of ergot alkaloids such as dihydroergotamine and ergotamine with Cetoderm Tablets is contraindicated.

Liver Disease

The use of Cetoderm Tablets are contraindicated in patients with acute or chronic liver disease.

Hypersensitivity

Cetoderm Tablets are contraindicated in patients who have shown hypersensitivity to the drug.

References

1. DailyMed. "KETOCONAZOLE: DailyMed provides trustworthy information about marketed drugs in the United States. DailyMed is the official provider of FDA label information (package inserts).". https://dailymed.nlm.nih.gov/dailyme... (accessed September 17, 2018).
2. DTP/NCI. "ketoconazole: The NCI Development Therapeutics Program (DTP) provides services and resources to the academic and private-sector research communities worldwide to facilitate the discovery and development of new cancer therapeutic agents.". https://dtp.cancer.gov/dtpstandard/s... (accessed September 17, 2018).
3. European Chemicals Agency - ECHA. "Ketoconazole: The information provided here is aggregated from the "Notified classification and labelling" from ECHA's C&L Inventory. ". https://echa.europa.eu/information-o... (accessed September 17, 2018).

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Information checked by Dr. Sachin Kumar, MD Pharmacology