Medically reviewed by Kovalenko Svetlana Olegovna, PharmD. Last updated on 26.06.2023
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A derivative of prednisolone with high glucocorticoid activity and low mineralocorticoid activity. Absorbed through the skin faster than fluocinonide, it is used topically in treatment of psoriasis but may cause marked adrenocortical suppression. [PubChem]
Batmax-GM cream (emollient) USP, 0.05% is a super-high potency corticosteroid indicated for:
Corticosteriod-Responsive Dermatoses
Batmax-GM cream (emollient) USP, 0.05% is indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses in patients 12 years of age and older. Treatment should be limited to 2 consecutive weeks, and the total dosage should not exceed 50 grams per week.
Moderate to Severe Plaque-Type Psoriasis
Batmax-GM cream (emollient) USP, 0.05% is indicated for the topical treatment of moderate to severe plaque-type psoriasis. Treatment beyond 4 consecutive weeks is not recommended. Use in pediatric patients under 16 years of age is not recommended.
Limitations of Use
Batmax-GM cream (emollient) USP, 0.05% should not be used in the treatment of rosacea or perioral dermatitis, and should not be used on the face, groin, or axillae.
The total dosage should not exceed 50 grams per week.
Avoid use if skin atrophy is present at the treatment site.
Treating inflammation and itching due to certain skin conditions. It may also be used for other conditions as determined by your doctor.
Batmax-GM is a topical adrenocortical steroid. It works by reducing skin inflammation (eg, redness, swelling, itching, irritation) in a way that is not clearly understood.
Batmax-GM (Batmax-GM scalp application) Application should be applied to the affected scalp areas twice daily, once in the morning and once at night.
Batmax-GM (Batmax-GM scalp application) Application is potent; therefore, treatment must be limited to 2 consecutive weeks and amounts greater than 50 mL/week should not be used.
Batmax-GM (Batmax-GM scalp application) Application is not to be used with occlusive dressings.
Geriatric Use: In studies where geriatric patients {65 years of age or older, see PRECAUTIONS) have been treated with Batmax-GM (Batmax-GM scalp application) Application, safety did not differ from that in younger patients; therefore, no dosage adjustment is recommended.
How supplied
Batmax-GM (Batmax-GM scalp application) Application, 0.05% is supplied in plastic squeeze bottles, 25 mL {NDC 0173-0432-00) and 50 mL (NDC 0173-0432-01). Store between 4° and 25°C (39° and 77°F). Do not use near an open flame.
Glaxo Wellcome Inc. Research Triangle Park, NC 27709. August 2000. FDA rev date: 4/2/2003
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What is the most important information I should know about Batmax-GM?
Batmax-GM (Batmax-GM scalp application) Application is contraindicated in patients with primary infections of the scalp, or in patients who are hypersensitive to Batmax-GM, other corticosteroids, or any ingredient in this preparation.
Use Batmax-GM shampoo as directed by your doctor. Check the label on the medicine for exact dosing instructions.
- Separate the hair to expose the area of the scalp where the medicine will be applied. Apply medicine only to a dry scalp. Apply a thin film of medicine to the affected area. Avoid getting the medicine onto unaffected areas of skin. Gently massage the medicine into the area. Repeat for all areas of the scalp that require treatment with the medicine.
- Leave the medicine on the scalp for 15 minutes or as long as directed by your doctor. After leaving the medicine on the scalp for the prescribed length of time, add water to your hair and work into lather. Rinse the hair well. Rinse your hands and any area of skin, such as the neck, face, or shoulders, which may have come into contact with the medicine. Wash your hands after applying Batmax-GM shampoo.
- No additional shampoo is needed to cleanse your hair after using Batmax-GM shampoo. However, you may wash your hair with additional, non-medicated shampoo if desired.
- Do not place bandages or other coverings over the areas being treated.
- If you miss a dose of Batmax-GM shampoo, use it as soon as possible. If several hours have passed or if it is nearing time for the next dose, do not double the dose to catch up, unless advised by your health care provider. If more than one dose is missed, contact your health care provider or pharmacist.
Ask your health care provider any questions you may have about how to use Batmax-GM shampoo.
There are specific as well as general uses of a drug or medicine. A medicine can be used to prevent a disease, treat a disease over a period or cure a disease. It can also be used to treat the particular symptom of the disease. The drug use depends on the form the patient takes it. It may be more useful in injection form or sometimes in tablet form. The drug can be used for a single troubling symptom or a life-threatening condition. While some medications can be stopped after few days, some drugs need to be continued for prolonged period to get the benefit from it.Batmax-GM is used to treat itching, redness, dryness, swelling, and discomfort of various scalp and skin conditions, including immune-mediated skin disease with red scaly patches (psoriasis).
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What other drugs will affect Batmax-GM?
* If you are taking this product under your doctor’s direction, your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring you for them.
* Do not start, stop, or change the dosage of any medicine before checking with your doctor or pharmacist first. If prescribed by your doctor, tell your doctor or pharmacist of all prescription or nonprescription/herbal products you may use before using this product.
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What are the possible side effects of Batmax-GM?
The following adverse reactions are discussed in greater detail in other sections of the labeling:
- Effects on Endocrine System
Ophthalmic Adverse Reactions
Clinical Trials Experience
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 controlled clinical trials involving 821 subjects exposed to Batmax-GM foam, 0.05% (emulsion) and vehicle foam, the pooled incidence of local adverse reactions in trials for atopic dermatitis and psoriasis with Batmax-GM foam, 0.05% (emulsion) was 1.9% for application site atrophy and 1.6% for application site reaction. Most local adverse events were rated as mild to moderate and they were not affected by age, race, or gender.
Postmarketing Experience
Because these 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.
The following adverse reactions have been identified during post-approval use of Batmax-GM formulations: erythema, pruritus, burning, alopecia, and dryness.
The following additional local adverse reactions have been reported with topical corticosteroids: folliculitis, acneiform eruptions, hypopigmentation, perioral dermatitis, allergic contact dermatitis, secondary infection, irritation, striae, and miliaria. They may occur more frequently with the use of occlusive dressings and higher potency corticosteroids, such as Batmax-GM.
Cushing's syndrome has been reported in infants and adults as a result of prolonged use of topical Batmax-GM formulations.
Ophthalmic adverse reactions may include cataracts, glaucoma, increased intraocular pressure, and central serous chorioretinopathy.