Itraconazole Oral Solution
Itraconazole
10mg/mL
Oral Solution
Antifungal for oral use in cats only
Description:
Itraconazole is a yellow to slightly amber, clear solution containing the active ingredient, itraconazole, at 10 mg/mL. Itraconazole is an antifungal medication widely used in veterinary medicine to treat a variety of fungal infections in animals, particularly in cats and dogs. It's effective against a range of fungi and is used to treat infections like：Dermatophytosis,Aspergillosis,Cryptococcosis,Blastomycosis,Histoplasmosis,Systemic Mycoses.
Itraconazole works by inhibiting the enzyme that fungi need to build their cell membranes, ultimately leading to the death of the fungal cells. It's typically used when the infection is severe, widespread, or resistant to other antifungal medications. The chemical name of Itraconazole is (2R,4S)-rel-1-[(2,4-Dichlorophenyl)-2-(1H-1,2,4-triazol-1-ylmethyl)-1,3-dioxolan-4-ylmethyl]-1H-1,2,4-triazole-1-ethanol. The structural formula of itraconazole is:
Indications:
Itraconazole oral solution is indicated for the treatment of dermatophytosis caused by Microsporum canis in cats. Its use in dogs, small mammals, and some exotics to treat fungal infections is 'off label' or 'extra label'.
Dosage and Administration:
The solution should be administered orally using the enclosed graduated dosing syringe.
The daily dosage is 5 mg/kg (0.5 mL/kg) body weight administered once daily on alternating weeks for 3 treatment cycles. Cats are treated during weeks 1, 3, and 5, and left untreated during weeks 2 and 4.
Each line on the dosing syringe represents 0.1 mL of oral solution.
Dose Table for Itraconazole
The solution should be administered orally using the enclosed graduated dosing syringe. Keep the bottle upright and insert the dosing syringe through the opening of the top of the bottle (Figure 1). Do not invert the bottle (Figure 2). Fill the syringe by pulling the plunger until it reaches the graduation corresponding to the correct mL dose as indicated at the top of the syringe ring (Figure 3). Treat the cat by slowly and gently administering the liquid into the mouth, allowing the cat to swallow the product (Figure 4).
After dosing, do not replace syringe in the bottle. Rinse and dry the syringe. The bottle cap should be screwed back on tightly.
Contraindications:
Do not administer to cats with hypersensitivity to Itraconazole.
Warnings:
User Safety Warnings
Not for use in humans. Keep this and all medications out of reach of children. Wash hands and exposed skin after use. In case of accidental contact with eyes, rinse thoroughly with water. In case of pain or irritation, seek medical advice. In case of accidental ingestion, rinse mouth with water and seek medical advice.
Special precautions for person administering the veterinary product to the animal:
Microsporum canis dermatophytosis is a zoonotic disease (a disease that can be transmitted from animals to humans); therefore consult a physician if a suspected lesion occurs on a human. Wear protective gloves when handling the animal during treatment or when cleaning the syringe. Wash hands and exposed skin after handling the animal.
Itraconazole has not been shown to be sporicidal; therefore in order to reduce zoonotic potential, environmental contamination, and to decrease course of the disease, topical and environmental treatment should also be utilized.
Animal Safety Warnings
Itraconazole oral solution has not been shown to be safe in pregnant cats. Itraconazole oral solution should only be used in pregnant or lactating cats when the benefits outweigh the potential risks.
Keep Itraconazole oral solution in a secure location out of reach of dogs, cats, and other animals to prevent accidental ingestion or overdose.
Adverse Reactions:
Itraconazole, like all medications, can have side effects in animals, although not all animals will experience these. The side effects can vary depending on the species, the health status of the animal, and the duration of treatment. Here are some of the common side effects observed in cats and dogs:
For Cats:
Gastrointestinal Issues: Nausea, vomiting, and diarrhea are the most common side effects. Some cats may also experience decreased appetite.
Liver Toxicity: Elevated liver enzymes or liver toxicity can occur, particularly with long-term use. Monitoring liver function is important.
Skin Reactions: Less commonly, cats may develop skin issues, such as itchiness or rashes.
For Dogs:
Gastrointestinal Distress: Similar to cats, dogs can experience vomiting, diarrhea, and decreased appetite.
Liver Issues: Liver enzyme elevations and liver toxicity are potential side effects, especially in long-term treatments.
Neurological Effects: In rare cases, dogs may show neurological signs, such as depression or temporary loss of coordination.
General Side Effects in Animals:
Allergic Reactions: Allergic reactions are possible and can manifest as itching, hives, or in severe cases, difficulty breathing.
Interactions with Other Medications: Itraconazole can interact with other drugs, potentially leading to increased side effects.
It's important to monitor your pet closely for any signs of side effects and report them to your veterinarian.
Clinical Pharmacology
The mode of action of Itraconazole is based on its highly selective binding ability to fungal cytochrome p-450 iso-enzymes. This inhibits the synthesis of ergosterol and affects membrane-bound enzyme function and membrane permeability. This effect is irreversible and causes structural degeneration of the fungal organism.
Itraconazole is an antifungal medication used in veterinary medicine to treat a variety of fun gal infections in animals, primarily in cats and dogs. Its mechanism of action is focused on disrupting the fungal cell's ability to maintain and build its cell membrane, which is crucial for its survival. The pharmacokinetics of Itraconazole in animals, particularly in cats and dogs, are important for understanding how the drug works within their bodies and for determining the appropriate dosing and administration. Here's an overview:
Targeting Fungal Cell Membranes:Itraconazole works by inhibiting an enzyme called lanosterol 14 α-demethylase. This enzyme is involved in the synthesis of ergosterol, which is a key component of fungal cell membranes.
Inhibition of Ergosterol Synthesis: By inhibiting the enzyme, Itraconazole prevents the synthesis of ergosterol. Ergosterol is akin to cholesterol in animal cells – it's vital for maintaining the structure and function of the fungal cell membrane.
Disruption of Fungal Cell Function: With the production of ergosterol hindered, the cell membrane of the fungus becomes weak and dysfunctional. This leads to leakage of cell components and ultimately causes the death of the fungal cell.
Broad Spectrum of Action: Itraconazole is effective against a wide range of fungi, making it useful for treating various fungal infections like dermatophytosis (ringworm), aspergillosis, cryptococcosis, and more.
Storage conditions
Store at 68-77°F (20-25°C). Excursions permitted between 59-86°F (15-30°C)
Generic medication and its counterpart to have the same active ingredients, strength, quality, route of administration, and safety standards.All of our products are produced in GMP factories, Your pet’s health is our top priority.
This summary contains important information about Itraconazole. You should read this information before you start giving your dog Itraconazole and review it each time the prescription is refilled as there may be new information. This sheet is provided only as a summary and does not take the place of instructions from your veterinarian. Talk with your veterinarian if you do not understand any of this information or if you want to know more about Itraconazole.
What is Itraconazole?
Itraconazole is an antifungal medication widely used in veterinary medicine to treat a variety of fungal infections in animals, particularly in cats and dogs. It's effective against a range of fungi and is used to treat infections like：
Dermatophytosis: Commonly known as ringworm, a skin infection caused by various types of fungi.
Aspergillosis: A fungal infection caused by Aspergillus species, which can affect the respiratory system, among other areas.
Cryptococcosis: A serious fungal infection caused by Cryptococcus species, often affecting the respiratory system, central nervous system, and eyes.
Blastomycosis: Caused by Blastomyces dermatitidis, this infection can affect the respiratory system, skin, and other body systems.
Histoplasmosis: Caused by Histoplasma capsulatum, affecting lungs, and sometimes other organs.
Systemic Mycoses: Itraconazole can also be used to treat other systemic fungal infections that are less common.
Itraconazole works by inhibiting the enzyme that fungi need to build their cell membranes, ultimately leading to the death of the fungal cells. It's typically used when the infection is severe, widespread, or resistant to other antifungal medications.
The medication is available in various forms, including capsules, oral solution, and compounded formulations. The dosage and duration of treatment with Itraconazole depend on the type and severity of the infection, as well as the species, size, and health status of the animal. It's important to complete the full course of medication as prescribed by a veterinarian, even if the symptoms appear to resolve, to prevent the recurrence of the infection.
What are the side effects of Itraconazole?
Itraconazole, like all medications, can have side effects in animals, although not all animals will experience these. The side effects can vary depending on the species, the health status of the animal, and the duration of treatment. Here are some of the common side effects observed in cats and dogs:
For Cats:
Gastrointestinal Issues: Nausea, vomiting, and diarrhea are the most common side effects. Some cats may also experience decreased appetite.
Liver Toxicity: Elevated liver enzymes or liver toxicity can occur, particularly with long-term use. Monitoring liver function is important.
Skin Reactions: Less commonly, cats may develop skin issues, such as itchiness or rashes.
For Dogs:
Gastrointestinal Distress: Similar to cats, dogs can experience vomiting, diarrhea, and decreased appetite.
Liver Issues: Liver enzyme elevations and liver toxicity are potential side effects, especially in long-term treatments.
Neurological Effects: In rare cases, dogs may show neurological signs, such as depression or temporary loss of coordination.
General Side Effects in Animals:
Allergic Reactions: Allergic reactions are possible and can manifest as itching, hives, or in severe cases, difficulty breathing.
Interactions with Other Medications: Itraconazole can interact with other drugs, potentially leading to increased side effects.
It's important to monitor your pet closely for any signs of side effects and report them to your veterinarian. They may adjust the dose or switch to a different medication if the side effects impact your pet's quality of life or health. Regular follow-ups are essential, particularly in cases of long-term treatment, to ensure the safety and effectiveness of the medication.
Always use Itraconazole under the guidance of a veterinarian, and do not adjust the dosage or discontinue the medication without consulting them. The decision to use Itraconazole should balance the benefits of treating the fungal infection against the potential risks of side effects.
What drug interactions should be noted when using Itraconazole?
When using Itraconazole in animals, especially in cats and dogs, it's important to be aware of potential drug interactions, as these can affect the efficacy and safety of the treatment. Here are some key drug interactions to note:
CYP3A4 Inhibitors and Inducers: Itraconazole is metabolized by the cytochrome P450 3A4 (CYP3A4) enzyme. Drugs that inhibit or induce this enzyme can affect Itraconazole levels. Inhibitors can increase its levels, potentially leading to toxicity, while inducers can decrease its levels, reducing efficacy.
Other Antifungal Medications: Combining Itraconazole with other antifungal drugs, especially those that work similarly, can increase the risk of side effects or lead to reduced effectiveness.
Calcium Channel Blockers: These are used to treat heart conditions and high blood pressure. Itraconazole can increase the levels of these drugs, potentially leading to an increased risk of side effects.
Macrolide Antibiotics: Such as erythromycin, can interact with Itraconazole, leading to increased levels of either or both medications.
Anticoagulants: If Itraconazole is used with anticoagulants like warfarin, it can enhance the effects of the anticoagulant, increasing the risk of bleeding.
Chemotherapeutic Agents:Itraconazole can interact with certain chemotherapy drugs, affecting their metabolism and potentially leading to increased toxicity.
Anti-Seizure Medications: Some medications used to control seizures can be affected by Itraconazole, either by enhancing their effects or by being less effective.
Immunosuppressants: Drugs like cyclosporine can interact with Itraconazole; the antifungal can increase the levels of the immunosuppressant, potentially leading to toxicity.
H2 Blockers and Proton Pump Inhibitors: These are used to reduce stomach acid. They can decrease the absorption of Itraconazole, reducing its effectiveness.
Heartworm Preventatives: Some heartworm medications might interact with Itraconazole, so it's important to discuss with the veterinarian if your pet is on a heartworm preventative.
It's essential to inform the veterinarian about all the medications and supplements your pet is taking before starting treatment with Itraconazole. The veterinarian can then manage any potential interactions by adjusting dosages or choosing alternative treatments. Monitoring the animal closely for any adverse effects when on Itraconazole, especially if other medications are involved, is also crucial.
What if I miss giving my pet the medication?
If you miss a dose, give it when you remember, but if it is close to the time for the next dose, skip the dose you missed and give it at the next scheduled time, and return to the regular dosing schedule. Never give your pet two doses at once or give extra doses.
Are there any risk factors for this medication?
Itraconazole should not be used by pets that are allergic to it or similar antifungals. It should be used with extreme caution in pets with liver disease or with low stomach acid production and used carefully in pets with heart disease. Itraconazole should be used with caution in pets that are pregnant, breeding, or nursing, as its safety has not been established in these cases.
Is there any monitoring that needs to be done with this medication?
When using Itraconazole long-term, your veterinarian will monitor your pet’s liver values. Your veterinarian will monitor your pet to be sure that the medication is working. Monitor for any side effects and contact your veterinarian immediately if any side effects are observed.
What should I do in case of emergency?
If you suspect an overdose or an adverse reaction to the medication, call your veterinary office immediately. If they are not available, follow their directions in contacting an emergency facility.