Budesonide Capsules

Budesonide

0.5mg/1mg/3mg

Capsules

Oral durg corticosteroid to treat chronic (long-term) inflammation of the intestines used in animals

Description:

Budesonide is a glucocorticoid and an agonist of glucocorticoid receptors (EC50 = 45.7 pM in a transactivation assay). It is selective for glucocorticoid over mineralocorticoid receptors (EC50 = 7,620 pM). Budesonide inhibits LPS-induced TNF-α release from human peripheral blood mononuclear cells (PBMCs; IC50 = 0.96 nM). Budesonide is composed of a 1:1 mixture of epimers of the 16,17-butylacetal, creating a chiral center. The 22R-epimer binds to the GR with higher affinity than does the 22S-epimer (Table 33.5). The butyl acetal chain provided the highest potency for the homologous acetal chains. Its rate of topical uptake into epithelial tissue is more than 100 times faster than that for hydrocortisone and dexamethasone. Approximately 85% of the IV administered dose of budesonide undergoes extensive first-pass hepatic metabolism by CYP3A4 to its primary metabolites, 6β-hydroxybudesonide and 16α-hydroxyprednisolone, which have approximately 1/100 the potency of budesonide. This is an important inactivation step in limiting budesonide's systemic effect on adrenal suppression.

Budesonide is a corticosteroid used for its anti-inflammatory properties.Budesonide, when taken orally, is absorbed through the gastrointestinal tract. The chemical name of Budesonide is C25H34O6. The ctural formula of Budesonide is:

Indications:

Budesonide is  used in veterinary medicine, particularly for dogs and cats, due to its potent anti-inflammatory properties. The indications for BUDEVET in animals include:

Inflammatory Bowel Disease (IBD)

Allergic and Atopic Dermatitis

Respiratory Disorders

Autoimmune Disorders

Colitis and Other Gastrointestinal Disorders

It's important to note that while Budesonide can be effective in treating these conditions, its use in animals should always be under the guidance and prescription of a veterinarian.

Dosage and Administration:

The dosage and administration of Budesonide in animals, particularly in cats and dogs, must be carefully determined by a veterinarian. 

Inflammatory Bowel Disease (IBD) in Cats and Dogs:

Cats: The typical dosage range for cats is often between 0.5 mg to 1 mg per cat per day. 

Dogs: For dogs, the dosage is usually calculated based on weight. It might range from 0.1 mg/kg to 0.2 mg/kg once daily.

Budesonide is administered orally in the form of capsules.It's important to follow the veterinarian's instructions regarding whether to administer the medication with food or on an empty stomach, as this can affect absorption.

The duration of treatment with Budesonide will depend on the condition being treated and how well the animal responds to therapy. Some conditions may require long-term treatment.

Contraindications:

Budesonide while generally well-tolerated due to its targeted action and minimal systemic absorption, can still cause side effects in animals, particularly when used over a long period. The most commonly observed side effects in cats and dogs include:

• Known Hypersensitivity
• Systemic Fungal Infections
• Gastrointestinal Ulcers
• Liver Disease
• Pregnant or Nursing Animals
• Concurrent Infections
• Diabetes Mellitus
• Heart Disease
• Young Animals
• Immunization

Warnings:

User Safety Warnings: Not for use in humans. Keep this and all medications out of reach of children. Consult a physician in case of accidental ingestion by humans.

Animal Safety Warnings: Keep Budesonide in a secure location out of reach of dogs, cats, and other animals to prevent accidental ingestion or overdose.

It's critical to use Budesonide under veterinary supervision. A veterinarian can assess the risks and benefits for each individual animal and make recommendations based on their overall health, existing conditions, and current medications. Regular monitoring is also essential to ensure the safety and effectiveness of the treatment.

Adverse Reactions:

When used in animals, particularly in cats and dogs, Budesonide can have certain side effects. Common side effects of Budesonide in animals include:

• Increased Appetite and Weight Gain
• Increased Thirst and Urination
• Gastrointestinal Issues symptoms such as diarrhea, vomiting
• Behavioral Changes which could include increased energy, restlessness, or in rare cases, increased aggression.
• Immunosuppression
• Adrenal Suppression
• Possible Effects on Growth
• Alteration in Liver Enzymes
• Risk of Diabetes Mellitus

Clinical Pharmacology:

The clinical pharmacology of Budesonide in animals, particularly in veterinary patients like cats and dogs, involves several key aspects, including its pharmacokinetics (how the drug moves through the body) and pharmacodynamics (the drug's effects on the body). 

Absorption:

When administered orally, Budesonide is absorbed through the gastrointestinal tract. In animals, as in humans, it experiences significant first-pass metabolism in the liver, which reduces its systemic bioavailability.

The extent of absorption and the effect of food may vary between species.

Distribution:

Budesonide has a high degree of lipid solubility, allowing for extensive distribution into body tissues. It also binds significantly to plasma proteins.

The volume of distribution can be different in animals compared to humans, influenced by species-specific factors.

Metabolism:

Budesonide is extensively metabolized in the liver, primarily via the cytochrome P450 enzyme system. The metabolic pathways may vary among different animal species.

The resulting metabolites are generally less active than the parent compound, which is a desirable characteristic for reducing systemic side effects.

Elimination:

The metabolites of Budesonide are mainly excreted in the feces. A smaller proportion is excreted via the kidneys in the urine.

The elimination half-life can vary among different species, influenced by factors like liver function and age.

Pharmacodynamics:

Budesonide acts as an anti-inflammatory and immunosuppressive agent. It reduces inflammation by inhibiting the release of inflammatory mediators and suppressing the migration of inflammatory cells.

In animals, it's often used for conditions such as inflammatory bowel disease (IBD) due to its localized effect in the gut, reducing the potential for systemic steroid side effects.

Therapeutic Use:

In veterinary medicine, Budesonide is primarily used for treating IBD in cats and dogs, leveraging its potent anti-inflammatory effects while minimizing systemic absorption.

It may also be used in other conditions where corticosteroid therapy is indicated, but where a more targeted effect and fewer systemic side effects are desired.

Storage Information:

The oral capsules should be stored at room temperature, in a tight container, and in a dark and dry place. Short excursions in temperatures between 15°C and 30°C (59°F–86°F) are allowed.

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 Budesonide. You should read this information before you start giving your pet Budesonide 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 Budesonide.

What is Budesonide?

Budesonide is a corticosteroid medication used in veterinary medicine, particularly for cats and dogs, to treat a variety of conditions characterized by inflammation. It is valued for its potent anti-inflammatory effects and relatively low systemic absorption when used in certain formulations. Here are the primary uses of Budesonide in animals:

Inflammatory Bowel Disease (IBD): Budesonide is often used to treat IBD in cats and dogs. It reduces gastrointestinal inflammation, leading to an improvement in symptoms like diarrhea and vomiting. Budesonide is favored for this condition due to its localized action in the gut and fewer systemic side effects compared to other corticosteroids.

Allergic and Skin Conditions: In some cases, Budesonide may be used to manage allergic reactions and certain skin conditions that have an inflammatory component.

Respiratory Disorders: Although less common, it can be used for chronic respiratory conditions in animals, similar to its use in human asthma treatment.

What are the indications for Budesonide?

Budesonide is used in veterinary medicine for its anti-inflammatory and immunosuppressive properties, particularly in cats and dogs. Here are the key indications for Budesonide in animals:

Inflammatory Bowel Disease (IBD): Budesonide is commonly prescribed for cats and dogs suffering from IBD. It helps reduce gastrointestinal inflammation, which can alleviate symptoms like diarrhea, vomiting, and weight loss.

Chronic Respiratory Conditions: Although less common compared to its use in IBD, Budesonide may be used to manage chronic respiratory conditions in animals, similar to its use in treating asthma in humans.

Allergic Reactions and Skin Conditions: In some cases, Budesonide might be used to manage allergic reactions and certain dermatological conditions involving inflammation.

Autoimmune Disorders: Budesonide may be employed in the treatment of autoimmune disorders in animals, where suppression of the immune system's overactivity is necessary.

The use of Budesonide in veterinary medicine leverages its effectiveness in targeting inflammation with potentially fewer systemic side effects than other corticosteroids. This is particularly advantageous in managing chronic conditions. However, it should be used under strict veterinary supervision.

What are the side effects of Budesonide?

Budesonide while generally well-tolerated due to its targeted action and minimal systemic absorption, can still cause side effects in animals, particularly when used over a long period. The most commonly observed side effects in cats and dogs include:

Gastrointestinal Upset: Some animals may experience vomiting, diarrhea, or changes in appetite.

Increased Risk of Infections: As an immunosuppressive drug, Budesonide can increase the risk of infections, particularly with long-term use.

Behavioral Changes: Mood alterations or changes in behavior can sometimes occur.

Adrenal Suppression: Prolonged use of Budesonide can lead to suppression of the adrenal glands' normal function, which is a concern with all corticosteroids. This might result in reduced production of natural corticosteroids in the body.

Delayed Healing: Since corticosteroids like Budesonide can suppress the immune response, wound healing may be slower.

Polyuria and Polydipsia: Increased thirst and urination can occur in some cases.

Possible Weight Gain: As with other corticosteroids, Budesonide can sometimes lead to weight gain.

Hypersensitivity Reactions: Although rare, allergic reactions to Budesonide are possible.

Panting: Especially in dogs, prolonged use of Budesonide can sometimes result in increased panting.

It's important to closely monitor any animal being treated with Budesonide and report any side effects to a veterinarian. The vet may need to adjust the dosage or explore alternative treatments based on the animal's response. Regular follow-up is essential, especially for animals receiving long-term corticosteroid therapy, to manage any potential side effects and ensure the best possible outcome.

What drug interactions should be noted when using Budesonide?

When using Budesonide in animals, particularly in cats and dogs, it's important to be aware of potential drug interactions, as these can affect the efficacy and safety of the medication. Here are some key drug interactions to be aware of:

Nonsteroidal Anti-Inflammatory Drugs (NSAIDs): Combining Budesonide with NSAIDs can increase the risk of gastrointestinal ulcers or bleeding, given that both medications can affect the lining of the GI tract.

Other Corticosteroids: Concurrent use of Budesonide with other systemic corticosteroids can amplify the risk of corticosteroid-related side effects, including immunosuppression and adrenal suppression.

Cytochrome P450 Inhibitors: Drugs that inhibit the cytochrome P450 enzyme system, particularly CYP3A4 (like ketoconazole, itraconazole, and some other antifungal medications), can increase blood levels of Budesonide and thus its potential side effects.

Vaccines: As an immunosuppressive agent, Budesonide may reduce the efficacy of vaccines. It's advisable to consult with a veterinarian regarding vaccination schedules for animals taking Budesonide.

Diuretics: There can be an increased risk of electrolyte imbalances when Budesonide is used with certain diuretics.

Insulin and Oral Diabetes Medications: Since corticosteroids can increase blood glucose levels, they may counteract the effects of insulin and oral diabetes medications in diabetic animals.

Antacids and Proton Pump Inhibitors: These medications might interfere with the absorption of Budesonide, particularly if it's administered orally.

Immunosuppressants: Combining Budesonide with other immunosuppressive drugs can increase the risk of infections and other side effects related to immune system suppression.

It's crucial to inform your veterinarian about all the medications, supplements, and over-the-counter products your pet is taking before starting treatment with Budesonide.

What if I miss giving my pet the medication?

If you miss a dose, give it when you remember; however, if it is close to time for the next dose, skip the dose you missed, 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?

Budesonide should be avoided in pets that are allergic to the medication. It should be used cautiously in pets that have conditions such as gastrointestinal ulcers, active infections, diabetes mellitus, or cataracts, as these conditions are negatively affected by steroids. It should be avoided in pets undergoing a surgical or other stressful procedure.

Budesonide should be avoided in pregnant and lactating pets, and if it must be used, the benefits should outweigh the risks.

Is there any monitoring that needs to be done with this medication?

Monitor your pet for any adverse effects while on this medication. Your veterinarian may also monitor your pet to be sure that the medication is working.

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.