Azithromycin Compounded Oral Suspension

Description

Azithromycin Compounded Oral Suspension is a prescription antibiotic used by veterinarians to treat certain bacterial infections in animals. Azithromycin belongs to the macrolide class of antibiotics and may be prescribed for dogs, cats, and selected other species when a veterinarian determines that the infection is caused by susceptible bacteria. Depending on the animal's condition, azithromycin may be considered for certain respiratory, skin, soft tissue, and other bacterial infections.

Azithromycin works by interfering with bacterial protein synthesis, preventing susceptible bacteria from producing proteins needed for normal growth and reproduction. The medication distributes extensively into body tissues, including certain respiratory tissues, and remains active in the body for an extended period. Treatment selection should be based on the veterinarian's diagnosis and, when appropriate, bacterial culture and susceptibility testing. Azithromycin does not treat viral infections.

This chicken-flavored, oil based oral suspension is individually prepared by a compounding pharmacy according to a veterinarian's prescription. The liquid formulation allows individualized dosing and provides an alternative for animals that have difficulty swallowing tablets or capsules. Compounded Azithromycin Oral Suspension is not an FDA-approved finished drug product, and its use in animals is considered extra-label.

Uses & Benefits

• Used for veterinarian-diagnosed bacterial infections caused by susceptible organisms.

• May be prescribed for certain respiratory infections in dogs and cats.

• May be considered for selected skin and soft tissue infections.

• Provides antibacterial activity against certain susceptible gram-positive, gram-negative, and atypical bacteria.

• Distributes extensively into body tissues, including respiratory tissues.

• May be prescribed for certain other animal species when appropriate veterinary precautions are followed.

• Provides an oral liquid alternative for animals that have difficulty taking solid medications.

• Allows individualized dosing according to the animal's species, medical condition, and veterinary prescription.

How It Works

Azithromycin is a macrolide antibiotic that works by binding to the 50S subunit of bacterial ribosomes. This interferes with protein synthesis, preventing susceptible bacteria from producing proteins needed for growth and reproduction. Azithromycin is generally considered bacteriostatic, meaning it primarily inhibits bacterial growth, although it may have bactericidal activity against certain organisms under specific conditions. The medication distributes into tissues and accumulates within certain immune cells, contributing to its prolonged activity. Its effectiveness depends on the susceptibility of the bacteria causing the infection.

Indications

Susceptible Bacterial Respiratory Infections / Selected Skin and Soft Tissue Infections / Certain Atypical Bacterial Infections / Other Veterinarian-Diagnosed Susceptible Bacterial Infections

All listed veterinary uses are extra-label. This compounded preparation has no FDA-approved veterinary indications.

Ingredients

Active Ingredients:

Azithromycin

Inactive Ingredients:

Refer to the dispensing pharmacy for complete formulation specific inactive ingredient information.

Directions

Follow the prescription label exactly and veterinarian directions.

Administer Azithromycin Compounded Oral Suspension by mouth using an appropriately sized oral dosing syringe with clearly marked milliliter (mL) measurements. The veterinarian will determine the appropriate dose, administration frequency, and treatment duration based on the animal's species, weight, infection, medical history, and response to treatment.

Shake the bottle thoroughly before every dose to ensure the medication is evenly distributed throughout the suspension. Administer with or without food as directed by the veterinarian. If gastrointestinal upset occurs, the veterinarian may recommend giving the medication with a small amount of food.

Administer the medication at the prescribed intervals and complete the prescribed treatment course unless the veterinarian directs otherwise. Do not skip doses, change the prescribed amount, or discontinue treatment early without veterinary guidance.

If a dose is missed, contact the veterinarian or dispensing pharmacy for instructions. Do not double the next dose to compensate for a missed dose.

Handling of Your Oil Based Compounded Liquid

Azithromycin Compounded Oral Suspension is prepared as an oil based liquid. Because the medication is suspended in an oil vehicle, the contents may naturally separate into different layers during storage. The oil may rise toward the top of the bottle while suspended medication settles toward the bottom.

Separation during storage can be normal for this type of formulation and does not necessarily indicate a problem with the medication.

• Shake the bottle thoroughly before every dose.

• Ensure the medication appears evenly mixed before measuring the prescribed amount.

• Keep the bottle securely closed when not in use.

• Never add water or other liquids to the medication.

• Contact the dispensing pharmacy if the medication does not mix evenly after thorough shaking or develops an unusual appearance.

Dosing Instructions

When supplied with a bottle adapter and oral dosing syringe, follow these instructions:

1. Shake the bottle thoroughly before every dose.

2. Pull the dosing syringe plunger back to the prescribed dose line.

3. Insert the syringe tip firmly into the center of the bottle adapter.

4. Turn the bottle upside down while holding the syringe securely.

5. Push the syringe plunger completely inward.

6. Slowly pull the plunger back until the prescribed amount has been drawn into the syringe.

7. Confirm the correct volume has been measured and remove large air bubbles.

8. Turn the bottle upright before removing the syringe.

9. Remove the syringe from the bottle adapter.

10. Slowly administer the medication into the side of the animal's mouth, allowing time to swallow.

The bottle adapter should remain in place between doses if that is how the medication is packaged. Do not remove it unless instructed by the dispensing pharmacy.

Always use an appropriately sized oral dosing syringe with clearly marked milliliter measurements. Do not use household teaspoons or tablespoons to measure medication.

Caring for Your Dosing Syringe

Oil based medications may leave residue inside the dosing syringe. Over time, this residue can cause the plunger to drag, stick, or become difficult to move.

To help maintain proper syringe function:

1. Remove the plunger from the syringe barrel after administration if the syringe is designed to be disassembled.

2. Rinse the syringe barrel and plunger with warm water.

3. Wash with a small amount of mild dish soap to remove oil residue, if permitted by the syringe manufacturer.

4. Rinse thoroughly to remove all soap.

5. Allow the syringe and plunger to dry completely before reassembling and using again.

Additional syringe care recommendations:

• Do not boil, microwave, or place the syringe in a dishwasher unless permitted by the manufacturer.

• Do not modify or enlarge the syringe opening.

• Replace damaged syringes or syringes with unreadable measurement markings.

• Follow dispensing pharmacy instructions when they differ from general cleaning recommendations.

Cautions

• Veterinarian Prescription Required (Rx). Use only for the animal for which the medication was prescribed.

• Compounded Azithromycin Oral Suspension is not an FDA-approved finished drug product.

• Use in dogs, cats, or other species only when specifically prescribed by a veterinarian.

• Do not administer to animals with a known hypersensitivity to azithromycin, erythromycin, or other macrolide antibiotics.

• Use cautiously in animals with liver disease or a history of significant liver dysfunction.

• Use cautiously in animals with known cardiac rhythm abnormalities or conditions that increase the risk of QT interval prolongation.

• Azithromycin may cause gastrointestinal disturbances, including vomiting, diarrhea, and decreased appetite.

• Serious allergic reactions and liver injury are possible, although uncommon.

• Certain medications that affect heart rhythm may increase the risk of adverse cardiovascular effects when used with azithromycin.

• Inform the veterinarian about all prescription medications, supplements, and other products the animal receives.

• Oral macrolide antibiotics can cause severe, potentially fatal gastrointestinal complications in adult horses and should not be administered to them.

• Use in foals requires careful veterinary supervision because macrolide antibiotics may cause reduced sweating and dangerous elevations in body temperature.

• Macrolide antibiotics may cause serious gastrointestinal complications in rabbits and certain other small herbivores. Do not administer without species-specific veterinary authorization.

• Do not use for viral infections or conditions that have not been evaluated by a veterinarian.

• Seek veterinary attention promptly if the animal develops severe or bloody diarrhea, persistent vomiting, collapse, difficulty breathing, facial swelling, or other signs of a serious reaction.

• Avoid unnecessary skin or eye contact with the medication. Wash hands after administration.

• This medication is not available for sale or shipment to California or Massachusetts residents.

• Keep out of reach of children and animals.

Possible Side Effects

Vomiting / Diarrhea / Soft Stools / Decreased Appetite / Abdominal Discomfort / Nausea / Lethargy / Allergic Reactions / Elevated Liver Enzymes / Liver Injury / Abnormal Heart Rhythm

Precautions

Before beginning treatment, inform the veterinarian about all medications, supplements, and medical conditions affecting the animal. Azithromycin should be prescribed for bacterial infections when the veterinarian determines that the suspected or identified organism is susceptible. Bacterial culture and susceptibility testing may be recommended, particularly for recurrent infections, severe infections, or cases that do not respond as expected.

Animals with preexisting liver disease may require additional monitoring because azithromycin is eliminated primarily through the liver and bile. Animals with certain heart rhythm disorders or those receiving medications associated with QT interval prolongation may require additional cardiovascular precautions.

Drug interactions should be evaluated before treatment. Certain antacids containing aluminum or magnesium may interfere with azithromycin absorption, and concurrent use with medications such as digoxin, warfarin, cyclosporine, or certain antiarrhythmic drugs may require additional veterinary assessment or monitoring.

Safety during pregnancy, breeding, and lactation has not been fully established across veterinary species. The veterinarian should evaluate the potential benefits and risks before prescribing azithromycin to pregnant or nursing animals.

Species-specific precautions are especially important. Macrolide antibiotics can cause life-threatening colitis in adult horses. When prescribed for foals, azithromycin may be used as part of specialized treatment protocols, but careful monitoring is necessary because reduced sweating and hyperthermia can occur. Extra-label use in food-producing animals must comply with applicable regulations, and the veterinarian must establish appropriate restrictions and withdrawal intervals when legally permitted.

The veterinarian may recommend follow-up examinations or additional testing to evaluate treatment response. Contact the veterinarian if symptoms worsen, new symptoms develop, or the infection does not improve as expected.

Compounded oral suspensions may differ from commercially manufactured azithromycin products in their inactive ingredients, absorption characteristics, and storage requirements. The compounded oil based formulation should not be substituted with a commercially manufactured water-based suspension or another dosage form without veterinary authorization.

Storage

Store Azithromycin Compounded Oral Suspension at room temperature according to the dispensing pharmacy's prescription label. This oil based compounded formulation does not require refrigeration unless the dispensing pharmacy provides different instructions.

Keep the bottle tightly closed and protected from excessive heat, direct sunlight, and freezing.

Because this is an oil based suspension, the liquid may naturally separate into layers during storage. This separation can be normal. Shake the bottle thoroughly before every dose to ensure the medication is evenly mixed before measuring.

Use the medication only through the beyond use date (BUD) printed on the prescription label. Do not use medication beyond that date, even if some remains in the bottle.

Follow the storage and beyond use date instructions for the compounded prescription rather than those provided for commercially manufactured azithromycin oral suspensions.

Keep medication securely stored away from children and animals.

Disposal

Dispose of unused or expired Azithromycin Compounded Oral Suspension through a medication take-back program when available or according to applicable local medication disposal requirements. Keep discarded medication and packaging securely inaccessible to children and animals.