Novacort

Name: Novacort

Novacort Drug Class

Novacort is part of the drug classes:

  • Anesthetics for topical use

  • Local anesthetics

  • Corticosteroids acting locally

  • Corticosteroids for local oral treatment

  • Antiinflammatory Corticosteroids

  • Corticosteroids, weak group I

  • Corticosteroids, weak, other combinations

  • Corticosteroids/antiinfectives/mydriatics in combination

  • Glucocorticoids

Contraindications

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

Warnings and Precautions

General

For external use only. Systemic absorption of topical corticosteroids has produced reversible hypothalamic-pituitary-adrenal (HPA) axis suppression, manifestations of Cushing’s syndrome, hyperglycemia, and glucosuria in some patients. 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 over a large surface area and under an occlusive dressing should be evaluated periodically for the 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 usually 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. (See WARNINGS AND PRECAUTIONS-Pediatric Use.) Keep out of reach of children.

If irritation develops, topical corticosteroids should be discontinued and appropriate therapy instituted. Burning, itching, irritation, and dryness have been reported infrequently following the use of topical corticosteroids.

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 corticosteroid should be discontinued until the infection has been adequately controlled.

Information for the Patient:

Patients using topical corticosteroids should receive the following information and instructions:

  1. This medication is to be used as directed by the physician. It is for external use only. Avoid contact with the eyes.
  2. Patients should be advised not to use this medication for any disorder other than for which it was prescribed.
  3. The treated skin area should not be bandaged or otherwise covered or wrapped as to be occlusive unless directed by the physician.
  4. Patients should report any signs of local adverse reactions especially under occlusive dressing.
  5. 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.

Laboratory Tests:

The following tests may be helpful in evaluating the HPA axis suppression: (1) Urinary free cortisol test; and (2) ACTH stimulation test.

Carcinogenesis, Mutagenesis, and Impairment of Fertility: 

Long-term animal studies have not been performed to evaluate the carcinogenic potential or the effect on fertility of topical corticosteroids. Studies to determine mutagenicity with prednisolone and Hydrocortisone have revealed negative results.

Pregnancy. Teratogenic Effects. Category C: 

Corticosteroids are generally teratogenic in laboratory animals when administered systemically at relatively low dosage levels. The more potent corticosteroids have been shown to be teratogenic after dermal application in laboratory animals. There are no adequate and well-controlled studies in pregnant women on teratogenic effects from topically applied corticosteroids. Therefore, topical corticosteroids should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Drugs of this class should not be used extensively on pregnant patients, in large amounts, or for prolonged periods of time.

Nursing Mothers: 

It is not known whether topical administration of corticosteroids could result in sufficient systemic absorption to produce detectable amounts in breast milk. Systemically administered corticosteroids are secreted into breast milk in quantities NOT likely to have a deleterious effect on the infant. Nevertheless, caution should be exercised when topical corticosteroids are administered to a nursing woman.

Pediatric Use: 

Pediatric patients may demonstrate greater susceptibility to topical corticosteroid-induced HPA axis suppression and Cushing’s syndrome than mature patients because of a larger skin surface area to body weight ratio.

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 children 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 children 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.

Overdosage

Topically applied corticosteroids can be absorbed in sufficient amounts to produce systemic effects. (See WARNINGS AND PRECAUTIONS.)

How is Novacort Supplied

NDC #69646-704-26 29.0 gram gel tube

NDC #69646-704-02 2.0 gram gel sample – not for resale

NDC #69646-704-08 10-count carton of 2.0 gram gel sample packs - not for resale

NDC #69646-704-01 1.0 gram gel sample – not for resale

NDC #69646-704-38 10-count carton of 1.0 gram gel sample packs – not for resale            

Each 1.0 gram gel pack contains multiple doses depending on the surface area treated.

Each 2.0 gram gel pack contains multiple doses depending on the surface area treated.

Principal display panel

NDC 69646-704-26
Novacort Gel
2% hydrocortisone acetate-
1% pramoxine HCl
Rx Only
Net Wt. 29.0 g (1.02 oz.)

Novacort 
hydrocortisone acetate and pramoxine hydrochloride gel
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:69646-704
Route of Administration TOPICAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
HYDROCORTISONE ACETATE (HYDROCORTISONE) HYDROCORTISONE ACETATE 20 mg  in 1 g
PRAMOXINE HYDROCHLORIDE (PRAMOXINE) PRAMOXINE HYDROCHLORIDE 10 mg  in 1 g
Inactive Ingredients
Ingredient Name Strength
ALOE VERA LEAF  
BENZYL ALCOHOL  
CETYL ALCOHOL  
DIMETHICONE  
DIMETHYL ISOSORBIDE  
GLYCERIN  
GLYCERYL MONOSTEARATE  
HYPROMELLOSES  
POLYOXYL 100 STEARATE  
PHENOXYETHANOL  
POLOXAMER 407  
PROPYLENE GLYCOL  
WATER  
STEAROXYTRIMETHYLSILANE  
STEARYL ALCOHOL  
HAMAMELIS VIRGINIANA TOP WATER  
Packaging
# Item Code Package Description
1 NDC:69646-704-08 10 PACKET in 1 CARTON
1 2 g in 1 PACKET
2 NDC:69646-704-38 10 PACKET in 1 CARTON
2 1 g in 1 PACKET
3 NDC:69646-704-01 1 g in 1 PACKET
4 NDC:69646-704-02 2 g in 1 PACKET
5 NDC:69646-704-26 29 g in 1 TUBE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
UNAPPROVED DRUG OTHER 03/01/2015
Labeler - Novum Pharma, LLC (079736743)
Revised: 08/2017   Novum Pharma, LLC
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