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Procto-Med HC

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Overview

What is Procto-Med HC?

The topical corticosteroids constitute a class of primarily syn thetic steroids used as anti-inflammatory and anti- pruritic agents. Hydrocortisone cream is a member of this class. Hydrocortisone cream contains the synthetic steroid hydrocortisone (Pregn-4-ene-3,20-dione, 11, 17, 21-tri hydroxy-, (11ß)-) which has a molecular formula of CHO, a molecular weight of 362.46 and CAS Registry Number 50-23-7.

Each gram of the 2.5% cream contains 25 mg of hydrocortisone USP in a cream base of cetyl alcohol, citric acid, glyceryl stearate, isopropyl myristate, methylparaben, polyoxyl 40 stearate, polysorbate 60, propylene glycol, propylparaben, purified water, sodium citrate, sorbic acid, sorbitan monostearate, stearyl alcohol, white wax and citric acid solution and sodium citrate solution to adjust pH.



What does Procto-Med HC look like?



What are the available doses of Procto-Med HC?

Sorry No records found.

What should I talk to my health care provider before I take Procto-Med HC?

Sorry No records found

How should I use Procto-Med HC?

Topical corticosteroids are indicated for the relief of the inflammatory and pruritic manifestations of cortico steroid-responsive dermatoses.

Topical corticosteroids are generally applied to the affected area as a thin film from 2 to 4 times daily depending on the severity of the condition.

Occlusive dressings may be used for the management of psoriasis or recalcitrant conditions.

If an infection develops, the use of occlusive dressings should be discontinued and appropriate antimicrobial therapy instituted.


What interacts with Procto-Med HC?

Topical corticosteroids are contraindicated in those patients with a history of hypersensitivity to any of the components of the preparation.



What are the warnings of Procto-Med HC?

Sorry No Records found


What are the precautions of Procto-Med HC?



General:

Conditions which augment systemic absorption include the application of the more potent steroids, use over large surface areas, prolonged use, and the addition of occlusive dressings.

Therefore, patients receiving a large dose of a potent topical steroid applied to a large surface area or under an occlusive dressing should be evaluated periodically for evidence of HPA axis suppression by using the urinary free cortisol and ACTH stimulation tests. If HPA axis suppression is noted, an attempt should be made to withdraw the drug, to reduce the frequency of application, or to substitute a less potent steroid.

Recovery of HPA axis function is generally prompt and complete upon discontinuation of the drug. Infrequently, signs and symptoms of steroid withdrawal may occur, requiring supplemental systemic corticosteroids.

Children may absorb proportionally larger amounts of topical corticosteroids and thus be more susceptible to systemic toxicity

If irritation develops, topical corticosteroids should be discontinued and appropriate therapy instituted. In the presence of dermatological infections, the use of an appropriate antifungal or antibacterial agent should be instituted. If a favorable response does not occur promptly, the cortico steroid should be discontinued until the infection has been adequately controlled.



  • This medication is to be used as directed by the physician. It is for external use only. Avoid contact with the eyes.
  • Patients should be advised not to use this medication for any disorder other than for which it was prescribed.
  • The treated skin area should not be bandaged or otherwise covered or wrapped as to be occlusive unless directed by the physician.
  • Patients should report any signs of local adverse reactions especially under occlusive dressing.
  • Parents of pediatric patients should be advised not to use tight-fitting diapers or plastic pants on a child being treated in the diaper area, as these garments may constitute occlusive dressings.


Information for the Patient:



Laboratory Tests:



Carcinogenesis, Mutagenesis, Impairment of Fertility:



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Hypothalamic-pituitary-adrenal (HPA) axis suppression, Cushing’s syndrome and intracranial hypertension have been reported in children receiving topical corticosteroids. Manifestations of adrenal suppression in pediatric patients include linear growth retardation, delayed weight gain, low plasma cortisol levels, and absence of response to ACTH stimulation. Manifestations of intracranial hypertension include bulging fontanelles, headaches and bilateral papilledema.

Administration of topical corticosteroids to pediatric patients should be limited to the least amount compatible with an effective therapeutic regimen. Chronic corticosteroid therapy may interfere with the growth and development of children.


What are the side effects of Procto-Med HC?

The following local adverse reactions are reported infrequently with topical corticosteroids, but may occur more frequently with the use of occlusive dressings. These reactions are listed in approximate decreasing order of occurrence: burning, itching, irritation, dryness, folliculitis, hypertrichosis, acneiform eruptions, hypopigmentation, perioral dermatitis, allergic contact dermatitis, maceration of the skin, secondary infection, skin atrophy, striae and miliaria.

To report SUSPECTED ADVERSE EVENTS, contact the FDA at 1-800-FDA-1088 or http://www.fda.gov/ for voluntary reporting of adverse reactions.


What should I look out for while using Procto-Med HC?

Topical corticosteroids are contraindicated in those patients with a history of hypersensitivity to any of the components of the preparation.


What might happen if I take too much Procto-Med HC?

Topically applied corticosteroids can be absorbed in sufficient amounts to produce systemic effects


How should I store and handle Procto-Med HC?

Carton containing two epinephrine injection, USP auto-injectors 0.3 mg: NDC 0115-1694-49. Carton containing one epinephrine injection, USP auto-injector 0.3 mg: NDC 0115-1694-30. Carton containing two epinephrine injection, USP auto-injectors 0.15 mg: NDC 0115-1695-49. Carton containing one epinephrine injection, USP auto-injector 0.15 mg: NDC 0115-1695-30. Rx onlyCarton containing two epinephrine injection, USP auto-injectors 0.3 mg: NDC 0115-1694-49. Carton containing one epinephrine injection, USP auto-injector 0.3 mg: NDC 0115-1694-30. Carton containing two epinephrine injection, USP auto-injectors 0.15 mg: NDC 0115-1695-49. Carton containing one epinephrine injection, USP auto-injector 0.15 mg: NDC 0115-1695-30. Rx onlyProduct: 50090-2931NDC: 50090-2931-0 30 g in a TUBE Product: 50090-2931NDC: 50090-2931-0 30 g in a TUBE