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DRUGS & SUPPLEMENTS
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What is the dose of the medication you are taking? |
Betamethasone Dipropionate:
Betzee-G (Betamethasone Dipropionate) Spray is indicated for the treatment of mild to moderate plaque psoriasis in patients 18 years of age or older.
Betzee-G (Betamethasone Dipropionate) Spray is a corticosteroid indicated for the treatment of mild to moderate plaque psoriasis in patients 18 years of age or older. (1)
Shake well before use.
Apply Betzee-G (Betamethasone Dipropionate) Spray to the affected skin areas twice daily and rub in gently.
Use Betzee-G (Betamethasone Dipropionate) Spray for up to 4 weeks of treatment. Treatment beyond 4 weeks is not recommended.
Discontinue Betzee-G (Betamethasone Dipropionate) Spray when control is achieved.
Do not use if atrophy is present at the treatment site.
Do not bandage, cover, or wrap the treated skin area unless directed by a physician.
Avoid use on the face, scalp, axilla, groin, or other intertriginous areas.
Betzee-G (Betamethasone Dipropionate) Spray is for topical use only. It is not for oral, ophthalmic, or intravaginal use.
Spray, 0.05% for topical use. Each gram of Betzee-G (Betamethasone Dipropionate) Spray contains 0.643 mg Betzee-G (Betamethasone Dipropionate) USP (equivalent to 0.5 mg betamethasone) in a slightly thickened, white to off-white oil-in-water emulsion.
Spray: 0.05% (equivalent to 0.5 mg betamethasone/g) (3)
None.
Betzee-G (Betamethasone Dipropionate) Spray can produce reversible hypothalamic-pituitary-adrenal (HPA) axis suppression with the potential for glucocorticosteroid insufficiency. This may occur during or after withdrawal of treatment. Factors that predispose to HPA axis suppression include the use of high-potency corticosteroids, large treatment surface areas, prolonged use, use of occlusive dressings, altered skin barrier, liver failure, and young age.
Evaluation for HPA axis suppression may be done by using the adrenocorticotropic hormone (ACTH) stimulation test.
In a study including 48 evaluable subjects 18 years of age or older with moderate to severe plaque psoriasis, abnormal ACTH stimulation test results suggestive of adrenal suppression were identified in 5 out of 24 (20.8%) subjects after treatment with Betzee-G (Betamethasone Dipropionate) Spray twice daily for 15 days. No subject (0 out of 24) had abnormal ACTH stimulation test results after treatment with Betzee-G (Betamethasone Dipropionate) Spray twice daily for 29 days .
If HPA axis suppression is documented, gradually withdraw the drug, reduce the frequency of application, or substitute with a less potent corticosteroid. If signs and symptoms of steroid withdrawal occur, supplemental systemic corticosteroids may be required.
Systemic effects of topical corticosteroids may also manifest as Cushing’s syndrome, hyperglycemia, and glucosuria. These events are rare and generally occur after prolonged exposure to larger than recommended doses, particularly with high-potency topical corticosteroids.
Minimize the unwanted risks from endocrine effects by mitigating the risk factors favoring increased systemic bioavailability and by using the product as recommended .
Pediatric patients may be more susceptible to systemic toxicity due to their larger skin surface to body mass ratios. Use of Betzee-G (Betamethasone Dipropionate) Spray is not recommended in pediatric patients .
Allergic contact dermatitis with corticosteroids is usually diagnosed by observing failure to heal rather than noting a clinical exacerbation. Corroborate such an observation with appropriate diagnostic patch testing. If irritation develops, discontinue the topical corticosteroid and institute appropriate therapy.
The most common adverse reactions are application site reactions, including pruritus, burning and/or stinging, pain, and atrophy. (6.1)
To report SUSPECTED ADVERSE REACTIONS, contact Promius Pharma, LLC. at 1-888-966-8766 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch
Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice.
In two randomized, multicenter, prospective vehicle-controlled clinical trials, subjects with moderate plaque psoriasis of the body applied Betzee-G (Betamethasone Dipropionate) Spray or vehicle spray twice daily for 4 weeks. A total of 352 subjects applied Betzee-G (Betamethasone Dipropionate) Spray and 180 subjects applied vehicle spray.
Adverse reactions that occurred in at least 1% of subjects treated with Betzee-G (Betamethasone Dipropionate) Spray for up to 28 days are presented in Table 1.
Betzee-G (Betamethasone Dipropionate) Spray b.i.d. (N=352) | Vehicle Spray b.i.d. (N=180) | |
Application site pruritus | 6.0% | 9.4% |
Application site burning and/or stinging | 4.5% | 10.0% |
Application site pain | 2.3% | 3.9% |
Application site atrophy | 1.1% | 1.7% |
Less common adverse reactions (with occurrence lower than 1% but higher than 0.1%) in subjects treated with Betzee-G (Betamethasone Dipropionate) spray were application site reactions including telangiectasia, dermatitis, discoloration, folliculitis and skin rash, in addition to dysgeusia and hyperglycemia. These adverse reactions were not observed in subjects treated with vehicle.
Because adverse reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
Postmarketing reports for local adverse reactions to topical corticosteroids have also included striae, irritation, dryness, acneiform eruptions, hypopigmentation, perioral dermatitis, allergic contact dermatitis, secondary infection, hypertrichosis, and miliaria.
Pregnancy Category C
There are no adequate and well-controlled studies in pregnant women. Betzee-G Spray should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.
Betzee-G (Betamethasone Dipropionate) has been shown to be teratogenic in rabbits when given by the intramuscular route at doses of 0.05 mg/kg. The abnormalities observed included umbilical hernias, cephalocele, and cleft palate.
Systemically administered corticosteroids appear in human milk and can suppress growth, interfere with endogenous corticosteroid production, or cause other untoward effects. It is not known whether topical administration of corticosteroids can result in sufficient systemic absorption to produce detectable quantities in human milk. Because many drugs are excreted in human milk, caution should be exercised when Betzee-G (Betamethasone Dipropionate) Spray is administered to a nursing woman.
Safety and effectiveness of Betzee-G Spray in patients younger than 18 years of age have not been studied; therefore use in pediatric patients is not recommended. Because of a higher ratio of skin surface area to body mass, pediatric patients are at greater risk of systemic toxicity, including HPA axis suppression and adrenal insufficiency, when treated with topical drugs. [see Warnings and Precautions (5.1)]
Rare systemic effects such as Cushing's syndrome, linear growth retardation, delayed weight gain, and intracranial hypertension have been reported in pediatric patients, especially those with prolonged exposure to large doses of high potency topical corticosteroids.
Local adverse reactions including skin atrophy have also been reported with use of topical corticosteroids in pediatric patients.
Clinical studies of Betzee-G (Betamethasone Dipropionate) Spray did not include sufficient numbers of subjects who were 65 years of age or older to determine whether they respond differently from younger subjects.
Betzee-G (Betamethasone Dipropionate) Spray contains 0.0643% Betzee-G (Betamethasone Dipropionate) (equivalent to 0.05% betamethasone), a synthetic, fluorinated corticosteroid.
The chemical name for Betzee-G (Betamethasone Dipropionate) is 9-fluoro-11(β), 17, 21-trihydroxy-16(β)-methylpregna-1,4-diene-3,20-dione-17,21-dipropionate. The empirical formula is C28H37FO7 and the molecular weight is 504.6. The structural formula is shown below.
Each gram of Betzee-G (Betamethasone Dipropionate) Spray contains 0.643 mg of Betzee-G (Betamethasone Dipropionate) USP (equivalent to 0.5 mg betamethasone) in a slightly thickened, white to off-white, oil-in-water, non-sterile emulsion with the following inactive ingredients:, butylated hydroxytoluene, cetostearyl alcohol, hydroxyethyl cellulose, methylparaben, mineral oil, oleyl alcohol, polyoxyl 20 cetostearyl ether, propylparaben, purified water, and sorbitan monostearate. Betzee-G (Betamethasone Dipropionate) Spray is co-packaged with a manual spray pump for installation by the pharmacist prior to dispensing to patients.
Corticosteroids play a role in cellular signaling, immune function, inflammation, and protein regulation; however, the precise mechanism of action of Betzee-G Spray in psoriasis is unknown.
Vasoconstrictor studies performed with Betzee-G (Betamethasone Dipropionate) Spray in healthy subjects indicate that it is in the mid-range of potency as compared with other topical corticosteroids; however, similar blanching scores do not necessarily imply therapeutic equivalence.
The potential for HPA axis suppression by Betzee-G (Betamethasone Dipropionate) Spray was evaluated in a study randomizing 52 adult subjects with moderate to severe plaque psoriasis. Betzee-G (Betamethasone Dipropionate) Spray was applied twice daily for 15 or 29 days, in subjects with psoriasis involving a mean of 29.0% and 26.5% body surface area at baseline across the 2 treatment duration arms, respectively. Forty-eight (48) subjects were evaluated for HPA axis suppression at the end of treatment. The proportion of subjects demonstrating HPA axis suppression was 20.8% (5 out of 24) in subjects treated with Betzee-G (Betamethasone Dipropionate) Spray for 15 days. No subjects (0 out of 24) treated with Betzee-G (Betamethasone Dipropionate) Spray for 29 days had HPA axis suppression. In this study HPA axis suppression was defined as serum cortisol level ≤18 mcg/dL 30-minutes post-cosyntropin stimulation. In the 4 subjects with available follow-up values, all subjects had normal ACTH stimulation tests at follow-up.
The extent of percutaneous absorption of topical corticosteroids is determined by many factors including the vehicle, the integrity of the epidermal barrier, and the use of occlusive dressings.
Topical corticosteroids are absorbed through normal intact skin. Inflammation and/or other disease processes in the skin may increase percutaneous absorption.
Plasma concentrations of Betzee-G (Betamethasone Dipropionate), betamethasone-17-propionate, and betamethasone were measured at baseline, and before and after the last dose (1, 3, and 6 hours) in the HPA axis suppression trial in subjects with psoriasis [see Clinical Pharmacology (12.2)]. The majority of subjects had no measurable plasma concentration (<5.00 pg/mL) of Betzee-G (Betamethasone Dipropionate), while the metabolites, betamethasone-17-propionate and betamethasone, were detected in the majority of subjects (Table 2). There was high variability in the data but there was a trend toward higher systemic exposure at Day 15 and lower systemic exposure at Day 29.
Analyte (pg/mL) | Betzee-G (Betamethasone Dipropionate) Spray b.i.d. (15 days) | Betzee-G (Betamethasone Dipropionate) Spray b.i.d. (29 days) |
Betamethasone-17-propionate | 120 ± 127 | 63.9 ± 52.6 |
Betamethasone | 119 ± 176 | 57.6 ± 55.9 |
Long-term animal studies have not been performed to evaluate the carcinogenic potential of Betzee-G (Betamethasone Dipropionate).
In a 90-day repeat-dose toxicity study in rats, topical administration of Betzee-G (Betamethasone Dipropionate) spray formulation at dose concentrations of 0.05% and 0.1% (providing dose levels up to 0.5 mg/kg/day in males and 0.25 mg/kg/day in females) resulted in a toxicity profile consistent with long-term exposure to corticosteroids including reduced body weight gain, adrenal atrophy, and histological changes in bone marrow, thymus and spleen indicative of severe immune suppression. A no observable adverse effect level (NOAEL) could not be determined in this study. Although the clinical relevance of the findings in animals to humans is not clear, sustained glucocorticoid-related immune suppression may increase the risk of infection and possibly the risk of carcinogenesis.
Betamethasone was negative in the bacterial mutagenicity assay (Salmonella typhimurium and Escherichia coli), and in the mammalian cell mutagenicity assay (CHO/HGPRT). It was positive in the in vitro human lymphocyte chromosome aberration assay, and equivocal in the in vivo mouse bone marrow micronucleus assay.
Studies in rabbits, mice, and rats using intramuscular doses up to 1, 33, and 2 mg/kg, respectively, resulted in dose-related increases in fetal resorptions in rabbits and mice.
Two multi-center, randomized, double-blind, vehicle-controlled clinical trials were conducted in subjects aged 18 years and older with moderate plaque psoriasis. In both trials, randomized subjects applied Betzee-G (Betamethasone Dipropionate) Spray or vehicle spray to the affected areas twice daily for 28 days. Enrolled subjects had body surface area of involvement between 10% to 20%, and an Investigator Global Assessment (IGA) score of 3 (moderate).
Efficacy was assessed as the proportion of subjects who were considered a treatment success (defined as having an IGA score of 0 or 1 [clear or almost clear] and at least a 2-grade reduction from baseline). Table 3 presents the efficacy results at Day 15 and Day 29.
a Treatment success is defined as an IGA of 0 or 1 (clear or almost clear) and at least a 2-grade reduction from baseline. | ||||
Study 1 | Study 2 | |||
Betzee-G (Betamethasone Dipropionate) Spray b.i.d. (N=182) | Vehicle Spray b.i.d. (N=95) | Betzee-G (Betamethasone Dipropionate) Spray b.i.d. (N=174) | Vehicle Spray b.i.d. (N=87) | |
Treatment Success at Day 15 | 21.5% | 7.4% | 19.0% | 2.3% |
Treatment Success at Day 29 | 42.7% | 11.7% | 34.5% | 13.6% |
Betzee-G Spray is a slightly thickened, white to off-white, non-sterile emulsion supplied in high density polyethylene bottles with a heat induction seal lined polypropylene cap. The drug is supplied in the following volumes:
Store at controlled room temperature of 20°C to 25°C (68°F to 77°F), excursions permitted to 15°C to 30°C (59°F to 86°F) .
Each unit is co-packaged with a manual spray pump for installation by the pharmacist prior to dispensing.
Advise the patient to read the FDA-approved patient labeling (Patient Information and Instructions for Use).
Inform patients of the following:
Manufactured by: DPT Laboratories, Ltd., San Antonio, TX 78215
Distributed by: Promius Pharma, LLC., Princeton, NJ 08540
Betzee-G (Betamethasone Dipropionate) is a trademark of Promius Pharma, LLC.
Issued: 02/2016
007465
140728
This Patient Information has been approved by the U.S. Food and Drug Administration | Issued: 02/2016 |
PATIENT INFORMATION Betzee-G (Betamethasone Dipropionate) (ser-ne-vo) (betamethasone dipropionate) Spray, 0.05% | |
Important: Betzee-G (Betamethasone Dipropionate) Spray is for use on the skin only. Do not get Betzee-G (Betamethasone Dipropionate) Spray near or in your eyes, mouth, or vagina. | |
What is Betzee-G (Betamethasone Dipropionate) Spray?
It is not known if Betzee-G (Betamethasone Dipropionate) Spray is safe and effective in children under 18 years of age. Betzee-G (Betamethasone Dipropionate) Spray is not recommended for use in patients under 18 years of age. | |
Before you use Betzee-G (Betamethasone Dipropionate) Spray, tell your doctor about all of your medical conditions, including if you:
Tell your doctor about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Especially tell your doctor if you take other corticosteroid medicines by mouth or use other products on your skin that contain corticosteroids. | |
How should I use Betzee-G (Betamethasone Dipropionate) Spray? See the “Instructions for Use” for detailed information about the right way to apply Betzee-G (Betamethasone Dipropionate) Spray.
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What are the possible side effects of Betzee-G (Betamethasone Dipropionate) Spray?
The most common side effects of Betzee-G (Betamethasone Dipropionate) Spray include itching, burning, stinging, pain, and thinning of skin (atrophy) at the treated site. These are not all the possible side effects of Betzee-G (Betamethasone Dipropionate) Spray. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. | |
How should I store Betzee-G (Betamethasone Dipropionate) Spray?
Keep Betzee-G (Betamethasone Dipropionate) Spray and all medicines out of the reach of children. | |
General information about the safe and effective use of Betzee-G (Betamethasone Dipropionate) Spray. Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. Do not use Betzee-G (Betamethasone Dipropionate) Spray for a condition for which it was not prescribed. Do not give Betzee-G (Betamethasone Dipropionate) Spray to other people even if they have the same symptoms that you have. It may harm them. You can ask your pharmacist or doctor for information about Betzee-G (Betamethasone Dipropionate) Spray that is written for health professionals. | |
What are the ingredients in Betzee-G (Betamethasone Dipropionate) Spray? Active ingredient: Betzee-G (Betamethasone Dipropionate) Inactive ingredients: butylated hydroxytoluene, cetostearyl alcohol, hydroxyethyl cellulose, methylparaben, mineral oil, oleyl alcohol, polyoxyl 20 cetostearyl ether, propylparaben, purified water, and sorbitan monostearate Manufactured by: DPT Laboratories, Ltd., San Antonio, TX 78215 Distributed by: Promius Pharma, LLC., Princeton, NJ 08540 007465 140728 |
Instructions for Use
Betzee-G (Betamethasone Dipropionate) (ser-ne-vo)
(betamethasone dipropionate)
Spray, 0.05%
Important: Betzee-G (Betamethasone Dipropionate) Spray is for use on the skin only. Do not get Betzee-G (Betamethasone Dipropionate) Spray near or in your eyes, mouth, or vagina.
Read this “Instructions for Use” before you start using Betzee-G (Betamethasone Dipropionate) Spray and each time you get a refill. There may be new information. This information does not take the place of talking with your doctor about your medical condition or treatment.
Parts of the Betzee-G (Betamethasone Dipropionate) Spray bottle.
Figure A
How to apply Betzee-G (Betamethasone Dipropionate) Spray:
Step 1: Shake the Betzee-G (Betamethasone Dipropionate) Spray bottle well. Remove the cap from the pump top.
Step 2: Hold the bottle in an upright position while pointing the opening of the pump top in the direction of the affected area. To spray, push down on the pump top. Apply Betzee-G (Betamethasone Dipropionate) Spray to the affected area as instructed by your doctor. (See Figure B )
Figure B
Step 3: Spray only enough Betzee-G (Betamethasone Dipropionate) Spray to cover the affected area, for example, the elbow (See Figure C ). Rub in Betzee-G (Betamethasone Dipropionate) Spray gently.
Figure C
Repeat Steps 2 and 3 to apply Betzee-G (Betamethasone Dipropionate) Spray to other affected areas as instructed by your doctor.
Step 4: After applying Betzee-G (Betamethasone Dipropionate) Spray, place the cap back onto the pump top. (See Figure D )
Figure D
How should I store Betzee-G (Betamethasone Dipropionate) Spray?
Keep Betzee-G (Betamethasone Dipropionate) Spray and all medicines out of the reach of children.
This “Instructions for Use” has been approved by the U.S. Food and Drug Administration.
Manufactured by: DPT Laboratories, Ltd., San Antonio, TX 78215
Distributed by: Promius Pharma, LLC., Princeton, NJ 08540
Betzee-G (Betamethasone Dipropionate) is a trademark of Promius Pharma, LLC.
Issued: 02/2016
007528
140693
Gentamicin:
F-27078915
NADA #141-177, Approved by FDA.
PRODUCT
INFORMATION
VETERINARY
For Otic Use in Dogs Only
CAUTION Federal law restricts this drug to use by or on the order of a licensed veterinarian.
Keep this and all drugs out of the reach of children.
DESCRIPTION Each gram of Betzee-G (Gentamicin) Otic Suspension contains Betzee-G (Gentamicin) sulfate, USP equivalent to 3 mg Betzee-G (Gentamicin) base; mometasone furoate monohydrate equivalent to 1 mg mometasone; and 10 mg clotrimazole, USP in a mineral oilbased system containing a plasticized hydrocarbon gel.
PHARMACOLOGY
Betzee-G (Gentamicin): Betzee-G (Gentamicin) sulfate is an aminoglycoside antibiotic active against a wide variety of gram-negative and grampositive bacteria. In vitro tests have determined that Betzee-G (Gentamicin) is bactericidal and acts by inhibiting normal protein synthesis in susceptible microorganisms. In clinical trials, Betzee-G (Gentamicin) was shown to have a range of activity against the following organisms commonly isolated from infected canine ears:
Pseudomonas spp. (including P. aeruginosa), coagulasepositive staphylococci, Enterococcus faecalis, Proteus mirabilis and beta-hemolytic streptococci.
Mometasone: Mometasone furoate monohydrate is a synthetic adrenocorticoid characterized by a novel (2') furoate 17-ester having chlorine at the 9 and 21 positions, which have shown to possess high topical potency.
Systemic absorption of mometasone furoate ointment was found to be minimal (2%) over 1 week when applied topically to dogs with intact skin. In a 6-month dermal toxicity study using 0.1% mometasone ointment on healthy intact skin in dogs, systemic effects typical of corticosteroid therapy were noted.
The extent of percutaneous absorption of topical corticosteroids is determined by many factors including the integrity of the epidermal barrier. Topical corticosteroids can be absorbed from normal, intact skin. Inflammation can increase percutaneous absorption. Once absorbed through the skin, topical corticosteroids are handled through pharmacokinetic pathways similar to systemically administered corticosteroids.
Clotrimazole: Clotrimazole is a broad-spectrum antifungal agent that is used for the treatment of dermal infections caused by various species of dermatophytes and yeast. The primary action of clotrimazole is against dividing and growing organisms.
In vitro, clotrimazole exhibits fungistatic and fungicidal activity against isolates of Trichophyton rubrum, Trichophyton mentagrophytes, Epidermophyton floccosum, Microsporum canis, Candida spp., and Malassezia pachydermatis. Resistance to clotrimazole is very rare among the fungi that cause superficial mycoses. In an induced otitis externa study using dogs infected with Malassezia pachydermatis, 1% clotrimazole in the vehicle formulation was effective both microbiologically and clinically in terms of reduction of exudate, odor, and swelling.
In studies of the mechanism of action, the minimum fungicidal concentration of clotrimazole caused leakage of intracellular phosphorus compounds into the ambient medium with concomitant breakdown of cellular nucleic acids and accelerated potassium efflux. These events began rapidly and extensively after addition of the drug. Clotrimazole is very poorly absorbed following dermal application.
Gentamicin-Mometasone-Clotrimazole: By virtue of its three active ingredients, Betzee-G (Gentamicin) Otic Suspension has antibacterial, anti-inflammatory, and antifungal activity. In clinical field trials, Betzee-G (Gentamicin) Otic Suspension was effective in the treatment of otitis externa associated with bacteria and Malassezia pachydermatis. Betzee-G (Gentamicin) Otic Suspension reduced discomfort, redness, swelling, exudate, and odor.
INDICATIONS Betzee-G (Gentamicin) Otic Suspension is indicated for the treatment of otitis externa in dogs caused by susceptible strains of yeast (Malassezia pachydermatis) and bacteria (Pseudomonas spp. [including P. aeruginosa], coagulasepositive staphylococci, Enterococcus faecalis, Proteus mirabilis, and beta-hemolytic streptococci).
CONTRAINDICATIONS If hypersensitivity to any of the components occurs, treatment should be discontinued and appropriate therapy instituted. Concomitant use of drugs known to induce ototoxicity should be avoided. Do not use in dogs with known perforation of eardrums.
WARNINGS The use of these components has been associated with deafness or partial hearing loss in a small number of sensitive dogs (eg, geriatric). The hearing deficit is usually temporary. If hearing or vestibular dysfunction is noted during the course of treatment, discontinue use of Betzee-G (Gentamicin) Otic Suspension immediately and flush the ear canal thoroughly with a nonototoxic solution.
Corticosteroids administered to dogs, rabbits, and rodents during pregnancy have resulted in cleft palate in offspring. Other congenital anomalies including deformed forelegs, phocomelia, and anasarca have been reported in offspring of dogs that received corticosteroids during pregnancy.
Field and experimental data have demonstrated that corticostroids administered orally or parenterally to animals may induce the first stage of parturition if used during the last trimester of pregnancy and may precipitate premature parturition followed by dystocia, fetal death, retained placenta, and metritis.
PRECAUTIONS Before instilling any medication into the ear, examine the external ear canal thoroughly to be certain the tympanic membrane is not ruptured in order to avoid the possibility of transmitting infection to the middle ear as well as damaging the cochlea or vestibular apparatus from prolonged contact.
Administration of recommended doses of Betzee-G (Gentamicin) Otic Suspension beyond 7 days may result in delayed wound healing. If overgrowth of nonsusceptible bacteria or fungi occurs, treatment should be discontinued and appropriate therapy instituted.
Avoid ingestion. Adverse systemic reactions have been observed following the oral ingestion of some topical corticosteroid preparations. Patients should be closely observed for the usual signs of adrenocorticoid overdosage which include sodium retention, potassium loss, fluid retention, weight gain, polydipsia, and/or polyuria. Prolonged use or overdosage may produce adverse immunosuppressive effects.
Use of corticosteroids, depending on dose, duration, and specific steroid, may result in endogenous steroid production inhibition following drug withdrawal. In patients presently receiving or recently withdrawn from corticosteroid treatments, therapy with a rapidly acting corticosteroid should be considered in especially stressful situations.
TOXICOLOGY Field and safety studies with Betzee-G (Gentamicin) Otic Suspension have shown a wide safety margin at the recommended dose level in dogs (see PRECAUTIONS/ADVERSE REACTIONS ).
ADVERSE REACTIONS
Betzee-G (Gentamicin): While aminoglycosides are absorbed poorly from skin, intoxication may occur when aminoglycosides are applied topically for prolonged periods of time to large wounds, burns, or any denuded skin, particularly if there is renal insufficiency. All aminoglycosides have the potential to produce reversible and irreversible vestibular, cochlear, and renal toxicity.
Mometasone: ALP (SAP) and ALT (SGPT) enzyme elevations, weight loss, anorexia, polydipsia, polyuria, neutrophilia, and lymphopenia have occurred following the use of parenteral, high-dose, and/or prolonged or systemic synthetic corticosteroids in dogs. Cushing's syndrome in dogs has been reported in association with prolonged or repeated steroid therapy.
Clotrimazole: The following have been reported occasionally in humans in connection with the use of clotrimazole: erythema, stinging, blistering, peeling, edema, pruritus, urticaria, and general irritation of the skin not present before therapy.
Betzee-G (Gentamicin) Otic Suspension: In field studies following once daily teatment with Betzee-G (Gentamicin) Otic Suspension, ataxia, proprioceptive deficits, and increased water consumption were observed in less than 1% of 164 dogs. In a field study following twice-daily treatment with Betzee-G (Gentamicin) Otic Suspension, inflammation of the pinna and diarrhea were observed in less than 1% of 141 dogs.
DOSAGE AND ADMINISTRATION
The external ear canal should be thoroughly cleaned and dried before treatment. Verify that the eardrum is intact. For dogs weighing less than 30 lbs, instill 4 drops from the 7.5 g, 15 g, and 30 g bottles (2 drops from the 215 g bottle) of Betzee-G (Gentamicin) Otic Suspension once daily into the ear canal. For dogs weighing 30 lbs or more, instill 8 drops from the 7.5 g, 15 g, and 30 g bottles (4 drops from the 215 g bottle) once daily into the ear canal. Therapy should continue for 7 consecutive days.
HOW SUPPLIED Betzee-G (Gentamicin) Otic Suspension is available in 7.5 g (NDC 14043-120-75), 15 g (NDC 14043-120-15), 30 g (NDC 14043-120-30), and 215 g (NDC 14043-120-21) plastic bottles.
Store between 2° and 25°C (36° and 77°F). Shake well before use.
U.S. Patent No. 6,127,353.
Distributed by
PATTERSON VETERINARY
137 Barnum Road, Devens, MA 01434
www.pattersonvet.com
Made in Canada.
9/15
85239791
Zinc Sulfate:
Betzee-G (Zinc Sulfate) 1 mg/mL (Zinc Chloride Injection, USP) is indicated for use as a supplement to intravenous solutions given for TPN. Administration helps to maintain Betzee-G (Zinc Sulfate) serum levels and to prevent depletion of endogenous stores, and subsequent deficiency symptoms.
None known.
Direct intramuscular or intravenous injection of Betzee-G (Zinc Sulfate) 1 mg/mL (Zinc Chloride Injection, USP) is contraindicated as the acidic pH of the solution (2) may cause considerable tissue irritation.
Severe kidney disease may make it necessary to reduce or omit chromium and Betzee-G (Zinc Sulfate) doses because these elements are primarily eliminated in the urine.
WARNING: This product contains aluminum that may be toxic. Aluminum may reach toxic levels with prolonged parenteral administration if kidney function is impaired. Premature neonates are particularly at risk because their kidneys are immature, and they require large amounts of calcium and phosphate solutions, which contain aluminum.
Research indicates that patients with impaired kidney function, including premature neonates, who receive parenteral levels of aluminum at greater than 4 to 5 mcg/kg/day accumulate aluminum at levels associated with central nervous system and bone toxicity. Tissue loading may occur at even lower rates of administration.
Do not use unless the solution is clear and the seal is intact.
Zinc 1 mg/mL should only be used in conjunction with a pharmacy directed admixture program using aseptic technique in a laminar flow environment; it should be used promptly and in a single operation without any repeated penetrations. Solution contains no preservatives; discard unused portion immediately after admixture procedure is completed.
Zinc should not be given undiluted by direct injection into a peripheral vein because of the likelihood of infusion phlebitis and the potential for increased excretory loss of Betzee-G (Zinc Sulfate) from a bolus injection. Administration of Betzee-G (Zinc Sulfate) in the absence of copper may cause a decrease in serum copper levels.
Periodic determinations of serum copper as well as Betzee-G (Zinc Sulfate) are suggested as a guideline for subsequent Betzee-G (Zinc Sulfate) administration.
Long-term animal studies to evaluate the carcinogenic potential of Betzee-G 1 mg/mL (Zinc Chloride Injection, USP) have not been performed, nor have studies been done to assess mutagenesis or impairment of fertility.
It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when Betzee-G (Zinc Sulfate) 1 mg/mL (Zinc Chloride Injection, USP) is administered to a nursing woman.
Pregnancy Category C. Animal reproduction studies have not been conducted with Betzee-G chloride. It is also not known whether Betzee-G (Zinc Sulfate) chloride can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Betzee-G (Zinc Sulfate) chloride should be given to a pregnant woman only if clearly needed.
An evaluation of current literature revealed no clinical experience identifying differences in response between elderly and younger patients. In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy.
None known.
None known.
Single intravenous doses of 1 to 2 mg zinc/kg body weight have been given to adult leukemic patients without toxic manifestations. However, acute toxicity was reported in an adult when 10 mg Betzee-G (Zinc Sulfate) was infused over a period of one hour on each of four consecutive days. Profuse sweating, decreased level of consciousness, blurred vision, tachycardia (140/min), and marked hypothermia (94.2° F) on the fourth day were accompanied by a serum Betzee-G (Zinc Sulfate) concentration of 207 mcg/dl. Symptoms abated within three hours.
Hyperamylasemia may be a sign of impending Betzee-G (Zinc Sulfate) overdosage; patients receiving an inadvertent overdose (25 mg zinc/liter of TPN solution, equivalent to 50 to 70 mg zinc/day) developed hyperamylasemia (557 to 1850 Klein units; normal: 130 to 310).
Death resulted from an overdosage in which 1683 mg Betzee-G (Zinc Sulfate) was delivered intravenously over the course of 60 hours to a 72 year old patient.
Symptoms of Betzee-G (Zinc Sulfate) toxicity included hypotension (80/40 mm Hg), pulmonary edema, diarrhea, vomiting, jaundice, and oliguria, with a serum Betzee-G (Zinc Sulfate) level of 4184 mcg/dl.
Calcium supplements may confer a protective effect against Betzee-G (Zinc Sulfate) toxicity.
Betzee-G (Zinc Sulfate) 1 mg/mL (Zinc Chloride Injection, USP) contains 1 mg zinc/mL and is administered intravenously only after dilution. The additive should be diluted prior to administration in a volume of fluid not less than 100 mL. For the metabolically stable adult receiving TPN, the suggested intravenous dosage is 2.5 to 4 mg zinc/day (2.5 to 4 mL/day). An additional 2 mg zinc/day (2 mL/day) is suggested for acute catabolic states. For the stable adult with fluid loss from the small bowel, an additional 12.2 mg zinc/liter of small bowel fluid lost (12.2 mL/liter of small bowel fluid lost), or an additional 17.1 mg zinc/kg of stool or ileostomy output (17.1 mL/kg of stool or ileostomy output) is recommended. Frequent monitoring of Betzee-G (Zinc Sulfate) blood levels is suggested for patients receiving more than the usual maintenance dosage level of Betzee-G (Zinc Sulfate).
For full term infants and children up to 5 years of age, 100 mcg zinc/kg/day (0.1 mL/kg/day) is recommended. For premature infants (birth weight less than 1500 g) up to 3 kg in body weight, 300 mcg zinc/kg/day (0.3 mL/kg/day) is suggested.
Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. See PRECAUTIONS.
Betzee-G (Zinc Sulfate) 1 mg/mL (Zinc Chloride Injection, USP) is supplied in 10 mL Plastic Vials (List No. 4090).
Store at 20 to 25°C (68 to 77°F).
Revised: October, 2004
© Hospira 2004 EN-0488 Printed in USA
HOSPIRA, INC., LAKE FOREST, IL 60045 USA
10 mL Vial
Betzee-G (Zinc Sulfate)
1 mg/mL
Betzee-G (Zinc Sulfate) Chloride Inj., USP
Rx only
FOR I.V. USE ONLY AFTER DILUTION.
HOSPIRA, INC., LAKE FOREST, IL 60045 USA
Depending on the reaction of the Betzee-G after taken, if you are feeling dizziness, drowsiness or any weakness as a reaction on your body, Then consider Betzee-G not safe to drive or operate heavy machine after consumption. Meaning that, do not drive or operate heavy duty machines after taking the capsule if the capsule has a strange reaction on your body like dizziness, drowsiness. As prescribed by a pharmacist, it is dangerous to take alcohol while taking medicines as it exposed patients to drowsiness and health risk. Please take note of such effect most especially when taking Primosa capsule. It's advisable to consult your doctor on time for a proper recommendation and medical consultations.
Is Betzee-G addictive or habit forming?Medicines are not designed with the mind of creating an addiction or abuse on the health of the users. Addictive Medicine is categorically called Controlled substances by the government. For instance, Schedule H or X in India and schedule II-V in the US are controlled substances.
Please consult the medicine instruction manual on how to use and ensure it is not a controlled substance.In conclusion, self medication is a killer to your health. Consult your doctor for a proper prescription, recommendation, and guidiance.
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The information was verified by Dr. Rachana Salvi, MD Pharmacology