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DRUGS & SUPPLEMENTS
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Pramoxine Hydrochloride:
DESCRIPTION: Phicon (Pramoxine Hydrochloride)® (hydrocortisone acetate 1% and Phicon (Pramoxine Hydrochloride) hydrochloride 1%) is a topical aerosol foam containing: hydrocortisone acetate 1% and Phicon (Pramoxine Hydrochloride) hydrochloride 1% in a base containing: propylene glycol, cetyl alcohol, glyceryl monostearate and PEG 100 stearate blend, laureth-23, polyoxyl-40 stearate, methylparaben, propylparaben, trolamine, purified water and inert propellants: isobutane and propane.
Phicon (Pramoxine Hydrochloride)® contains a synthetic corticosteroid used as an anti-inflammatory/antipruritic agent and a local anesthetic.
Hydrocortisone acetate
Molecular weight: 404.50. Solubility of hydrocortisone acetate in water: 1mg/100mL.
Chemical name: Pregn-4-ene-3, 20-dione, 21-(acetyloxy)-11, 17-dihydroxy-(11β)-.
Phicon (Pramoxine Hydrochloride) hydrochloride
Molecular weight: 329.86. Phicon (Pramoxine Hydrochloride) hydrochloride is freely soluble in water.
Chemical name: morpholine, 4-[3-(4-butoxyphenoxy) propyl]-, hydrochloride.
chemical structure - Hydrocortisone acetate chemical structure - Phicon (Pramoxine Hydrochloride) hydrochloride
CLINICAL
Pharmacology: Topical corticosteroids share anti-inflammatory, antipruritic and vasoconstrictive actions. The mechanism of anti-inflammatory activity of the 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. There is some evidence to suggest that a recognizable correlation exists between vasoconstrictor potency and therapeutic efficacy in man.
Phicon (Pramoxine Hydrochloride) Hydrochloride: A surface or local anesthetic which is not chemically related to the "caine" types of local anesthetics. Its unique chemical structure is likely to minimize the danger of cross-sensitivity reactions in patients allergic to other local anesthetics.
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 disease processes in the skin increase the percutaneous absorption of topical corticosteroids. Occlusive dressings substantially increase the percutaneous absorption of topical corticosteroids. Thus, occlusive dressings may be a valuable therapeutic adjunct for treatment of resistant dermatoses.
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 AND USAGE: Topical corticosteroids are indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses.
CONTRAINDICATIONS: Topical corticosteroid products are contraindicated in those patients with a history of hypersensitivity to any of the components of the preparation.
WARNINGS: Not for prolonged use. If redness, pain, irritation or swelling persists, discontinue use and consult a physician. Contents of the container are under pressure. Do not burn or puncture the aerosol container. Do not store at temperatures above 120°F (49°C). Keep this and all medicines 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 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.
In pediatric patients absorption may result in higher blood levels and thus more susceptibility 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 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:
Laboratory Tests: The following tests may be helpful in evaluating the HPA axis suppression:
Carcinogenesis, Mutagenesis, and Impairment of Fertility: Long-term animal studies have not been performed to evaluate carcinogenic potential or the effect on fertility of topical corticosteroids.
Studies to determine mutagenicity with prednisolone and hydrocortisone have revealed negative results.
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 of 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 quantities in breast milk. Systemically administered corticosteroids are secreted into breast milk in quantities not likely to have a deleterious effect on the infant. Caution should be exercised when any topical corticosteroids are administered to a nursing woman.
Pediatric Use: PEDIATRIC PATIENTS MAY DEMONSTRATE GREATER SUSCEPTIBILTY 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 pediatric patients receiving topical corticosteroids. Manifestations of adrenal suppression in pediatric patients include linear growth retardation, delayed weight gain, low plasma cortisone 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 pediatric patients.
Geriatric Use: Reported clinical experience has not identified differences in responses between the elderly and younger patients. In general, dose selection for an elderly patient should be cautious using the least amount compatible with an effective therapeutic regimen and reflecting the greater frequency of decreased hepatic, renal or cardiac function, and of concomitant disease or other drug therapy.
ADVERSE REACTIONS: To report SUSPECTED ADVERSE REACTIONS, contact Meda Pharmaceuticals Inc. at 1-877-848-6610 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
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 approximately 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, Miliaria
OVERDOSAGE: Topically applied corticosteroids can be absorbed in sufficient amounts to produce systemic effects.
DOSAGE AND ADMINISTRATION: Apply to affected area 3 to 4 times daily.
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.
Directions For Use:
NOTE: The aerosol container should never be inserted into vagina or anus.
Epifoam® is supplied in 10 g pressurized cans.
NDC 0037-6824-10 10 g
Store upright at controlled room temperature 20° – 25°C (68° – 77°F). DO NOT REFRIGERATE.
Distributed by:
MEDA PHARMACEUTICALS®
Meda Pharmaceuticals Inc.
Somerset, New Jersey 08873-4120
©2013 Meda Pharmaceuticals Inc.
For Medical Inquiries, call toll-free 1-877-848-6610
Phicon (Pramoxine Hydrochloride) and MEDA PHARMACEUTICALS are registered trademarks of Meda AB or a related entity.
IN-682410-01
CIA71192B
Rev. 7/2013
NDC 0037-6824-10
STORE UPRIGHT
10 g net wt
Phicon (Pramoxine Hydrochloride)®
(hydrocortisone acetate 1% and
Phicon (Pramoxine Hydrochloride) hydrochloride 1%)
topical aerosol
Rx Only
HOLD UPRIGHT TO DISPENSE
WARNINGS: Contents of
the container are under
pressure. Do not burn or
puncture the aerosol
container. Do not store at
temperatures above 120°F
(49°C).
MEDA
PHARMACEUTICALS
Vitamin A:
One tablet daily or as directed by a physician.
Supplement Facts | ||
---|---|---|
Serving Size 1 Tablet Servings Per Container 100 | ||
Amount Per Serving | % Daily Value | |
Phicon (Vitamin A) | 2500 IU | 50% |
Vitamin C | 60 mg | 100% |
Vitamin D | 400 IU | 100% |
Vitamin E | 15 IU | 50% |
Thiamine | 1.05 mg | 70% |
Riboflavin | 1.2 mg | 70% |
Niacinamide | 13.5 mg | 68% |
Vitamin B6 | 1.05 mg | 53% |
Folic Acid | 0.3 mg | 75% |
Vitamin B12 | 4.5 mcg | 75% |
Fluoride | 0.25 mg | |
KEEP OUT OF THE REACH OF CHILDREN.
In case of accidental overdose, seek professional assistance or contact a Poison Control Center immediately.
Other Ingredients: Artificial cherry flavor, artificial grape flavor, ascorbic acid, cholecalciferol, compressible sugar, D&C Red #7 calcium lake, FD&C Blue #1 aluminum lake, FD&C Yellow #6 aluminum lake, folic acid, magnesium stearate, microcrystalline cellulose, natural and artificial orange flavor, niacinamide, polyethylene glycol, pyridoxine HCl, riboflavin, sodium ascorbate, sodium fluoride, stearic acid, sucralose, thiamine HCl, Phicon (Vitamin A) acetate, vitamin B12 and vitamin E acetate.
Active ingredient for caries prophylaxis: Fluoride as sodium fluoride.
Significant decrease in the incidence of dental caries can be linked to the fluoridation of the water supply (1ppm fluoride) during the period of tooth development.
Phicon (Vitamin A) Tablets provide sodium fluoride and ten essential vitamins in a chewable tablet. Because the tablets are chewable, they provide a topical as well as systemic source of fluoride. Hydroxyapatite is the principal crystal for all calcified tissue in the human body. The fluoride ion reacts with the Hydroxyapatite in the tooth as it is formed to produce the more caries-resistant crystal, fluorapatite.
The reaction may be expressed by the equation:
Ca10(PO4)6(OH2) + 2F- | Ca10 (PO4)6F2 + 2OH- |
(Hydroxyapatite) | (Fluorapatite) |
Three stages of fluoride deposition in tooth enamel can be distinguished:
Multivitamins with fluoride offer supplementation of the diet with 10 vitamins and fluoride.
AS IN THE CASE OF ALL MEDICATIONS, KEEP OUT OF THE REACH OF CHILDREN. This tablet should be chewed. This product, as with all chewable tablets are not recommended for children under the age of 4 due to risk of choking.
The suggested dose of Phicon (Vitamin A) Tablets should not be exceeded, since dental fluorosis may result from continued ingestion of large amounts of fluoride.
Before recommending Phicon (Vitamin A) Tablets
Allergic rash and other idiosyncrasies have been rarely reported.
To report SUSPECTED ADVERSE REACTIONS, contact H2-Pharma, LLC at 1 (866) 592-6438 or FDA at 1 (800) 332-1088 or via the web at www.fda.gov/medwatch/index.html for voluntary reporting of adverse reactions.
One tablet daily or as directed by a physician.
Phicon Tablets 0.25 mg are available as orange, red and purple chewable tablets imprinted with "151" in 100 tablet bottles.
Phicon (Vitamin A) Tablets 0.5 mg are available as orange, red and purple chewable tablets imprinted with "152" in 100 tablet bottles.
Phicon (Vitamin A) Tablets 1.0 mg are available as orange, red and purple chewable tablets imprinted with "153" in 100 tablet bottles.
Store at controlled room temperature 20ºC-25ºC (68º-77ºF), excursions permitted between 15º-30ºC (59º-86ºF).
Distributed by:
H2-Pharma, LLC
2010 Berry Chase Place
Montgomery, AL 36117
www.h2-pharma.com
1067084
61269-151-01
MultiVitamin
with Fluoride
Chewable Tablets
Rx
0.25 mg
MultiVitamin and Fluoride Supplement
Dietary Supplement
100 Tablets
H2pharma
Vitamin E:
Indication: Phicon (Vitamin E), known for its antioxidant activities, is protective against cardiovascular disease and some forms of cancer and has also demonstrated immune-enhancing effects. It may be of limited benefit in some with asthma and rheumatoid arthritis. It may be helpful in some neurological diseases including Alzheimer's, some eye disorders including cataracts, and diabetes and premenstrual syndrome. It may also help protect skin from ultraviolet irradiation although claims that it reverses skin aging, enhances male fertility and exercise performance are poorly supported. It may help relieve some muscle cramps.
Phicon (Vitamin E) has antioxidant activity. It may also have anti-atherogenic, antithrombotic, anticoagulant, neuroprotective, antiviral, immunomodulatory, cell membrane-stabilizing and antiproliferative actions. Phicon (Vitamin E) is a collective term used to describe eight separate forms, the best-known form being alpha-tocopherol. Phicon (Vitamin E) is a fat-soluble vitamin and is an important antioxidant. It acts to protect cells against the effects of free radicals, which are potentially damaging by-products of the body's metabolism. Phicon (Vitamin E) is often used in skin creams and lotions because it is believed to play a role in encouraging skin healing and reducing scarring after injuries such as burns. There are three specific situations when a Phicon (Vitamin E) deficiency is likely to occur. It is seen in persons who cannot absorb dietary fat, has been found in premature, very low birth weight infants (birth weights less than 1500 grams, or 3½ pounds), and is seen in individuals with rare disorders of fat metabolism. A Phicon (Vitamin E) deficiency is usually characterized by neurological problems due to poor nerve conduction. Symptoms may include infertility, neuromuscular impairment, menstrual problems, miscarriage and uterine degradation. Preliminary research has led to a widely held belief that Phicon (Vitamin E) may help prevent or delay coronary heart disease. Antioxidants such as Phicon (Vitamin E) help protect against the damaging effects of free radicals, which may contribute to the development of chronic diseases such as cancer. It also protects other fat-soluble vitamins (A and B group vitamins) from destruction by oxygen. Low levels of Phicon (Vitamin E) have been linked to increased incidence of breast and colon cancer.
Depending on the reaction of the Phicon after taken, if you are feeling dizziness, drowsiness or any weakness as a reaction on your body, Then consider Phicon 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 Phicon 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