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The following information outlines critical safety warnings and contraindications for the use of this medication. It is essential to understand these risks to ensure safe usage. Please discuss any concerns with your healthcare provider.

• Risk of Birth Defects: Pregnant women and those who may become pregnant should avoid handling dutasteride (Avodart) capsules. The medication can be absorbed through the skin and potentially harm an unborn baby. If contact with a leaking capsule occurs, wash the area immediately with soap and water.

• Impact on PSA Levels: Dutasteride (Avodart) can reduce prostate-specific antigen (PSA) levels, which are used to screen for prostate cancer. A new baseline PSA level should be established after three months of treatment, and levels should be monitored regularly. This reduction may impact prostate cancer testing accuracy.

• Increased Risk of Severe Prostate Cancer: There is a potential increased risk of developing a more severe form of prostate cancer when taking dutasteride (Avodart). In a study, 1% of men aged 50 to 75 who took the drug developed this condition. Consult your healthcare provider about this risk.

• Restrictions on Blood Donation: Do not donate blood while on dutasteride (Avodart) treatment and for at least six months after the final dose. The drug can remain in the bloodstream and pose a risk to pregnant women receiving a transfusion.

• Changes in Semen: Usage of dutasteride (Avodart) for one year has been associated with reduced sperm count and alterations in sperm. The impact on fertility is uncertain. If you have concerns, discuss them with your healthcare provider.

Contraindications:

• Pregnancy: The medication should not be used by those who are currently pregnant due to significant health risks.

• Allergy Considerations: Avoid using this medication if you have a known allergy to other 5 alpha-reductase inhibitors.

Please consult your healthcare provider if any of these conditions apply to you before starting treatment.

Common side effects:

• Trouble achieving or maintaining an erection
• Decreased sex drive
• Difficulty with ejaculation
• Trouble reaching orgasm
• Breast tenderness
• Breast enlargement
• Decreased interest in sexual activity
• Changes in semen production

Less common but important to monitor:

• Testicle pain
• Testicle swelling

Serious side effects:

• Severe allergic reactions characterized by skin peeling
• Swelling of the face, tongue, or throat
• Difficulty breathing

Dutasteride is primarily metabolized by the liver enzymes CYP3A4 and CYP3A5. When taken alongside medications that inhibit these enzymes, the breakdown of dutasteride can slow down, leading to higher levels of the drug in the bloodstream and an increased risk of side effects.

Medications that may increase dutasteride levels include:

• HIV Protease Inhibitors: Drugs such as Ritonavir, Atazanavir, and indinavir are potent CYP3A4 inhibitors and can elevate dutasteride concentrations.

• Antifungal Agents: Medications like Ketoconazole and Itraconazole can also inhibit CYP3A4, potentially increasing dutasteride levels.

• Calcium Channel Blockers: Drugs such as Verapamil and diltiazem may reduce the clearance of dutasteride, leading to higher drug levels.

• Other Medications: Cimetidine, used for heartburn, and Ciprofloxacin, an antibiotic, can similarly affect dutasteride metabolism.

While these interactions can lead to increased dutasteride levels, studies have shown that the incidence of adverse events remains similar between patients taking these medications with dutasteride and those taking a placebo. Nonetheless, caution is advised when combining dutasteride with potent, long-term CYP3A4 inhibitors.

On the other hand, dutasteride has been found to have no significant interactions with certain medications, including:

• Alpha-Adrenergic Antagonists: Tamsulosin and Terazosin, commonly used to treat BPH, do not significantly affect dutasteride levels when used together.

• Warfarin: A blood thinner, warfarin's effectiveness and breakdown are not altered by dutasteride.

• Digoxin: Used for heart conditions, digoxin's pharmacokinetics remain unchanged when taken with dutasteride.

• Cholestyramine: A medication for lowering cholesterol, cholestyramine does not affect the bioavailability of dutasteride.

It's important to note that while food may slightly delay the time it takes for dutasteride to reach peak concentration in the blood, this effect is not considered clinically significant. Therefore, dutasteride can be taken with or without food.

Given the potential for drug interactions, it's essential to inform your healthcare provider about all medications, supplements, and over-the-counter drugs you are currently taking before starting dutasteride.