Your browser does not support JavaScript! ZYPRAM (HYDROCORTISONE ACETATE AND PRAMOXINE HYDROCHLORIDE) CREAM [VERTICAL PHARMACEUTICALS, INC]
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ZYPRAM (hydrocortisone acetate and pramoxine hydrochloride) cream
[Vertical Pharmaceuticals, Inc]


Category DEA Schedule Marketing Status
HUMAN PRESCRIPTION DRUG LABEL unapproved drug other
NOTE:THIS DRUG HAS NOT BEEN FOUND BY FDA TO BE SAFE AND EFFECTIVE, AND THIS LABELING HAS NOT BEEN APPROVED BY FDA. For further information about unapproved drugs, click here.
Drug Label Sections

Rx Only

DESCRIPTION

ZyPram™ Cream is a topical preparation containing hydrocortisone acetate 2.35% in a cream base and pramoxine hydrochloride 1% in a hydrophilic cream base1. Hydrocortisone acetate has a chemical name pregn-4-ene-3, 20-dione, 21-(acetyloxy)-11,17-dihydroxy-(11β)-. It has the following structural formula:

Chemical Structure

Pramoxine hydrochloride has chemical name 4-[3-(4-butoxyphenoxy) propyl]morpholine hydrochloride, and has the following structure:

Chemical Structure

Active ingredients: Hydrocortisone Acetate 2.35% and Pramoxine Hydrochloride 1%.

Inactive ingredients: Ammonium Acryloyldimethyltaurate/VP-Copolymer, Benzyl Alcohol, Cetearyl Alcohol, Cetearyl Olivate (&) Sorbitan Olivate, PEG-12 Glyceryl Distearate=GDS-12, PEG-12 Glyceryl Dimyristate=GDM-12, Glycerine, Glyceryl Stearate, Methyl Paraben, PEG 100 Stearate, Polysorbate 60, Propylene Glycol, Purified Water, Sodium Lauryl Sulfate, White Petrolatum.

Cleansing Wipe (2.2 grams solution per wipe) Contains:

     Citric Acid . . . . . . . . . . . . . . . . . . . . . . . 22 mg

     Aloe Vera . . . . . . . . . . . . . . . . . . . . . . . 11 mg

     Vitamin E (dl-tocopheryl acetate) . . . . . . 2.2 mg

Inactive Ingredients: Water, Polysorbate 20, Phenoxyethanol, Methyl Paraben, Ethyl Paraben, Propyl Paraben, Butyl Paraben, Isobutyl Paraben, Extract Blend, Fragrance/Perfume.


1
This unique Lipid base delivery system provides more of the active ingredients, and out-performs traditional (active) ingredient applications.

CLINICAL PHARMACOLOGY

Topical corticosteroids share anti-inflammatory, anti-pruritic and vasoconstrictive actions. The mechanism of anti-inflammatory activity of topical corticosteroids is unclear. Various laboratory methods, including vasoconstrictor assays, are used to compare and predict potencies and/or clinical efficacies of the topical corticosteroids.

Pramoxine hydrochloride is a topical anesthetic agent which provides temporary relief from itching and pain. It acts by stabilizing the neuronal membrane of nerve endings with which it comes into contact.

PHARMACOKINETICS

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 can be absorbed from normal intact skin. Inflammation and/or other disease processes in the skin increase percutaneous absorption. Occlusive dressings substantially increase the percutaneous absorption of topical corticosteroids. Thus, occlusive dressings may be a valuable therapeutic adjunct for treatment of resistant dermatoses. (See DOSAGE AND ADMINISTRATION.)

Once absorbed through the skin, topical corticosteroids are handled through pharmacokinetic pathways similar to systemically administered corticosteroids. Corticosteroids are bound to plasma proteins in varying degrees. Corticosteroids are metabolized primarily in the liver and are then excreted by the kidneys. Some of the topical corticosteroids and their metabolites are also excreted into the bile.

INDICATIONS

ZyPram™ is used for anti-inflammatory and anesthetic relief of itching, pain and discomfort due to hemorrhoids, anal fissures, pruritus ani and similar conditions of the anal area.

CONTRAINDICATIONS

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

WARNINGS

For external use only. Not for ophthalmic use. Product could harm small children if chewed or swallowed. Individual tubes are NOT child resistant.

Keep product and cleansing wipes out of the reach of children.

PRECAUTIONS

General

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 to a large surface area and 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. (See Precautions-Pediatric Use.) 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 corticosteroid should be discontinued until the infection has been adequately controlled.

Directions for Using ZyPram™

Remove cleansing wipe from package and gently clean the affected area. Discard wipe after use (it is flushable). Remove cap from tube and puncture foil. Attach the provided applicator. Squeeze tube until the applicator is full. Gently insert the tip of the filled applicator approximately ½ inch into the anal area and squeeze the tube, applying ZyPram™ cream to the anus and the peri-anal area. Do not insert the applicator any additional length into the anus or into the rectum. Remove the applicator and tube. Thoroughly clean the applicator. If directed by a physician, a small amount of cream may be applied to the anal area using a fingertip.

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

Use in Pregnancy

Teratogenic Effects

Pregnancy 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.

ADVERSE REACTIONS

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 an approximate decreasing order of occurrence:

BurningDrynessPerioral dermatitisSkin atrophy
ItchingFolliculitis HypertrichosisAllergic contact dermatitisStriae
IrritationAcneiform eruptionsMaceration of the skinMiliaria
  HypopigmentationSecondary infection  

OVERDOSAGE

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

DOSAGE AND ADMINISTRATION

Apply ZyPram™ cream to the affected area(s) three times daily or as directed by a physician. ZyPram™ should not be used in excess of recommendations or for prolonged use in the anal canal. If the condition does not respond to repeated courses of ZyPram™, or should worsen, discontinue use and seek the advice of your physician. 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

HOW SUPPLIED

ZyPram™ NDC 68025-040-30, contains 1 tube 30 g, 2 wipes, 1 applicator and insert.

KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN.

Storage Conditions

Store at 20°-25°C (68°-77°F); excursions permitted to 15°-30°C (59°-86°F) [see USP Controlled Room Temperature].

05/09

Rx Only

Manufactured For:
Vertical Pharmaceuticals, Inc.
Sayreville, NJ 08872

Lipid Base Delivery System
QuSomes
U.S. Patent No. 6,610,322
U.S. Patent No. 6,958,160
U.S. Patent No. 7,150,883
2 Other patents pending


2
BioZone Laboratories, Inc. Qusomes™. Available at: http://www.biozonelabs.com/html/qusomes/qusomes.htm. Accessed 4/15/09.

PRINCIPAL DISPLAY PANEL-30 g Tube

NDC 68025-040-30

ZYPRAM™
(Hydrocortisone Acetate 2.35%, Pramoxine HCl 1%) Cream

For External Use Only
Not For Oral or Ophthalmic Use

Lipid Base Delivery System
QuSomes
U.S. Patent No. 6,610,322
U.S. Patent No. 6,958,160
U.S. Patent No. 7,150,883
* Other patents pending

Rx Only

VERTICAL
PHARMACEUTICALS, INC

Net Wt. 30 g

PRINCIPAL DISPLAY PANEL-30 g Tube

PRINCIPAL DISPLAY PANEL-30 g Carton

NDC 68025-040-30

ZYPRAM™
(Hydrocortisone Acetate 2.35%, Pramoxine HCl 1%) Cream

30 gram Tube
One Applicator
2 Cleansing Wipes

Rx Only

Lipid Base Delivery System
QuSomes
U.S. Patent No. 6,610,322
U.S. Patent No. 6,958,160
U.S. Patent No. 7,150,883
* Other patents pending

VERTICAL
PHARMACEUTICALS, INC

PRINCIPAL DISPLAY PANEL-30 g Carton
ZYPRAM 
hydrocortisone acetate and pramoxine hydrochloride cream
Product Information
Product TypeHUMAN PRESCRIPTION DRUG LABELItem Code (Source)NDC:68025-040
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Hydrocortisone Acetate (Hydrocortisone) Hydrocortisone705 mg  in 30 g
Pramoxine Hydrochloride (Pramoxine) Pramoxine300 mg  in 30 g
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:68025-040-3030 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
Unapproved other07/21/2009
Labeler - Vertical Pharmaceuticals, Inc (173169017)
Registrant - Sonar Products, Inc. (104283945)
Establishment
NameAddressID/FEIBusiness Operations
Sonar Products, Inc.104283945MANUFACTURE

Revised: 7/2009
 
Vertical Pharmaceuticals, Inc

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