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Diroban 25 mg/mL, 5 x 50 mg vials Rx

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Product Description

Diroban 25 mg/ml sterile powder for injection is indicated for the treatment of stabilized Class 1a, 2b, and 3c heartworm disease caused by immature (4 month-old, stage L5) to mature adult infections of Dirofilaria immitis in dogs. Diroban is currently the only FDA-approved drug available in the U.S. to treat canine heartworm disease. Comes in 5 x 50 mg vials + 5 x 2 ml sterile water vials.

What is Diroban 25 mg/mL, 5 x 50 mg vials?

Diroban 25 mg/ml sterile powder for injection is indicated for the treatment of heartworm disease in dogs.

Who is Diroban 25 mg/mL, 5 x 50 mg vials for?

Dogs

Why use Diroban 25 mg/mL, 5 x 50 mg vials?

-DIROBAN is currently the only FDA-approved drug available in the U.S. to treat canine heartworm disease

How does Diroban 25 mg/mL, 5 x 50 mg vials work?

Melarsomine dihydrochloride is an organic arsenical chemotherapeutic agent. Melarsomine has a molecular weight of 501.34 and is chemically designated as 4 - [(4, 6-diamino-1, 3, 5- triazon-2-yl) amino] phenyldithioarsenite of di (2-aminoethyl), dihydrochloride. It is freely soluble in water. When injected intramuscularly, it is rapidly absorbed. The exact mode of action on D. immitis is unknown.

Manufacturer:

Zoetis

Active ingredient(s):

50.0 mg melarsomine dihydrochloride and 33.75 mg glycine USP. 1 vial: when reconstituted with 2 mL of sterile water for injection (provided) contains 25 mg/mL of active ingredient

How is Diroban 25 mg/mL, 5 x 50 mg vials sold?

25 mg/mL, 5 x 50 mg vials of lyophilized melarsomine dihydrochloride with accompanying 5 x 2 mL vials of sterile water for injection USP

What are the side effects of Diroban 25 mg/mL, 5 x 50 mg vials?

ADVERSE REACTIONS (SIDE EFFECTS) : Injection Sites: At the recommended dosage in clinical field trials, significant irritation was observed at the intramuscular injection sites, accompanied by pain, swelling, tenderness, and reluctance to move. Approximately 30% of treated dogs experienced some kind of reaction at the injection site(s). Though injection site reactions were generally mild to moderate in severity and recovery occurred in 1 week to 1 month, severe reactions did occur (< 1.0%), so care should be taken to avoid superficial or subcutaneous injection and leakage. Firm nodules can persist indefinitely. Other Reactions: Coughing/gagging, depression/lethargy, anorexia/inappetence, fever, lung congestion, and vomiting were the most common reactions observed in dogs treated with melarsomine dihydrochloride. Hypersalivation and panting occurred rarely in clinical trials (1.9% and 1.6%, respectively); however, these signs may occur within 30 minutes of injection and may be severe. One dog vomited after each injection of melarsomine dihydrochloride, despite pretreatment with anti-emetics. All adverse reactions resolved with time or treatment with the exception of a limited number of injection site reactions (persistent nodules). CONTRAINDICATIONS : DIROBAN is contraindicated in dogs with very severe (Class 4) heartworm disease. Patients in this category have Caval Syndrome (D. immitis present in the venae cavae and right atrium).

What special precautions are there?

WARNING : DIROBAN should be administered by deep intramuscular injection ONLY in the epaxial (lumbar) muscles (L3 - L5). DO NOT USE IN ANY OTHER MUSCLE GROUP. DO NOT USE INTRAVENOUSLY. Care should be taken to avoid superficial injection or leakage (see SAFETY). WARNINGS : For use in dogs only. Safety for use in breeding animals and lactating or pregnant bitches has not been determined. HUMAN WARNINGS : Keep this and all medications out of the reach of children. Avoid human exposure. Wash hands thoroughly after use or wear gloves. Potentially irritating to eyes. Rinse eyes with copious amounts of water if exposed. Consult a physician in cases of accidental exposure by any route (dermal, oral, or by injection). PRECAUTIONS : General: All dogs with heartworm disease are at risk for post-treatment pulmonary thromboembolism (death of worms which may result in fever, weakness, and coughing), though dogs with severe pulmonary arterial disease have an increased risk and may exhibit more severe signs (dyspnea, hemoptysis, right heart failure and possibly death). Dogs should be restricted from light to heavy exercise post-treatment depending on the severity of their heartworm disease. Studies in healthy (heartworm negative) dogs indicate that adverse reactions may occur after the second injection in the series even if no problems were encountered with the first injection. All patients should be closely monitored during treatment and for up to 24 hours after the last injection

What to do if overdose?

Contact your nearest emergency animal hospital.

How can I store Diroban 25 mg/mL, 5 x 50 mg vials?

STORAGE CONDITIONS : Store upright at room temperature (15° - 30°C). After reconstitution, solutions should be stored under refrigeration and kept from light in the original packaging for 36 hours. Do not freeze reconstituted solution.

Helpful Tips:

Pharmacists are standing by to offer Pet Parent counseling regarding prescription medication purchased from Allivet before and after dispensing. Pharmacists on duty are available Monday-Friday, 9:30AM - 5:30PM EST and will be on call Saturday 12:00PM - 4:00PM EST for consultation.

Use as directed by your Veterinarian.


DOSAGE AND ADMINISTRATION : DIROBAN should be administered by deep intramuscular injection ONLY in the epaxial (lumbar) muscles in the third through fifth lumbar region. DO NOT ADMINISTER AT ANY OTHER SITE. Avoid superficial injection or leakage. Use a 23 gauge 1 inch needle for dogs equal to or less than 10 kg (22 lb) in weight. Use a 22 gauge 1½ inch needle for dogs greater than 10 kg (22 lb). Use alternating sides with each administration. If repeated administrations are warranted avoid injecting at the same lumbar location. Record the location of the first injection(s) in the patient’s medical record for future reference.

Disease Classification: It is vital to classify the severity of heartworm disease to apply the appropriate dosage regime for DIROBAN (see INDICATIONS).

Class 1 and 2:
If necessary, dogs should be stabilized prior to treatment. DIROBAN should be administered intramuscularly in the lumbar (L3 - L5) muscles at a dose of 2.5 mg/kg twice, 24 hours apart (see Dosing Table). Four months following treatment, a second treatment series (2.5 mg/kg twice, 24 hours apart) can be elected taking into consideration the response to the first DIROBAN treatment and the condition, age, and use of the dog. Worms that were too young to be killed by the first treatment series, i.e., < 4 months, may be killed by a second treatment series.

Class 3:
Alternate Dosing Regime: Dogs with severe (Class 3) heartworm disease should be stabilized prior to treatment and then dosed intramuscularly in the lumbar (L3 - L5) muscles with a single injection of 2.5 mg/kg then approximately 1 month later with 2.5 mg/kg administered twice 24 hours apart (see Dosing Table).

Dosing Table: Care must be taken to administer the proper dose. Accurately weigh the dog and calculate the volume to be injected based on the dose of 2.5 mg/kg (1.1 mg/lb). This is equivalent to 0.1 mL/kg (0.045 mL/lb). The following table should be used as a guide to ensure that the proper volume has been calculated.

WEIGHT (lb)                                  2.2 / 4.4 / 6.6 / 8.8 / 11 / 13.2 / 15.4 / 17.6 / 19.8 / 22 / 44 / 66 / 88 / 110
WEIGHT (kg)                                   1      2      3      4       5       6        7        8         9      10    20   30   40     50
VOLUME PER INJECTION (mL)    0.1  0.2   0.3   0.4    0.5    0.6      0.7      0.8     0.9    1.0    2.0  3.0  4.0    5.0*
*Limited data were collected on the administration > 5.0 mL at a single injection site.

Preparation: DIROBAN should be aseptically reconstituted only with 2.0 mL of sterile water for injection (provided as 2.0 mL sterile water for injection USP). This provides 2.5 mg melarsomine dihydrochloride per 0.1 mL of injectable solution. Two 50 mg vials will be required for dogs weighing > 20 kg and 40 kg and 3 vials will be required for dogs > 40 kg and 60 kg. Use immediately. Reconstituted solution may be used within 36 hours if refrigerated and kept from light.

Treatment Response: A baseline can be established pre-treatment by using commercially available in-office heartworm antigen test kits prior to treatment. Treatment response can be assessed best by heartworm antigen testing applied 4 months after treatment. A successful treatment is determined to be conversion from an antigen positive to an antigen negative status. In dogs with signs of heartworm disease, gradual improvement should be observed as the long-term effects of the heartworm infection resolve. Some dogs may have chronic effects that will not totally resolve.

Concomitant Therapy:
During the course of clinical field trials, DIROBAN was administered concurrently with anti-inflammatories, antibiotics, insecticides, heartworm prophylactics, and various other drugs commonly used to stabilize and support dogs with heartworm disease with no adverse drug interactions noted.

Routine Prophylaxis: If the dog is not currently receiving commercially available heartworm preventatives, they may be administered consistent with label recommendations and re-exposure risk.

50.0 mg melarsomine dihydrochloride and 33.75 mg glycine USP. 1 vial: when reconstituted with 2 mL of sterile water for injection (provided) contains 25 mg/mL of active ingredient. 

DIROBAN is provided as 5 x 50 mg vials of lyophilized melarsomine dihydrochloride with accompanying 5 x 2 mL vials of sterile water for injection USP

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Diroban 25 mg/mL, 5 x 50 mg vials

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