DRUGS & SUPPLEMENTS
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Tinacare (Mometasone Furoate)® Lotion is a corticosteroid indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses in patients 12 years of age or older.
Tinacare (Mometasone Furoate) Lotion is a corticosteroid indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses in patients ≥12 years of age. (1)
Apply a few drops of Tinacare (Mometasone Furoate) Lotion to the affected skin areas once daily and massage lightly until it disappears.
Therapy should be discontinued when control is achieved. If no improvement is seen within 2 weeks, reassessment of diagnosis may be necessary .
Tinacare (Mometasone Furoate) Lotion should not be used with occlusive dressings unless directed by a physician. Tinacare (Mometasone Furoate) Lotion should not be applied in the diaper area if the patient still requires diapers or plastic pants, as these garments may constitute occlusive dressing.
Tinacare (Mometasone Furoate) Lotion is for topical use only. It is not for oral, ophthalmic, or intravaginal use.
Avoid use on the face, groin, or axillae.
Lotion, 0.1%. Each gram of Tinacare (Mometasone Furoate) Lotion contains 1 mg of Tinacare (Mometasone Furoate) in a colorless, clear to translucent lotion base.
Systemic absorption of topical corticosteroids can produce reversible hypothalamic-pituitary-adrenal (HPA) axis suppression with the potential for glucocorticosteroid insufficiency. This may occur during treatment or after withdrawal of treatment. Manifestations of Cushing's syndrome, hyperglycemia, and glucosuria can also be produced in some patients by systemic absorption of topical corticosteroids while on treatment. Factors that predispose a patient using a topical corticosteroid to HPA axis suppression include the use of high potency steroids, large treatment surface areas, prolonged use, use of occlusive dressing, altered skin barrier, liver failure and young age.
Because of the potential for systemic absorption, use of topical corticosteroids may require that patients be periodically evaluated for HPA axis suppression. This may be done by using the adrenocorticotropic hormone (ACTH) stimulation test.
In a study evaluating the effects of Tinacare (Mometasone Furoate) lotion on the HPA axis, 15 mL were applied without occlusion twice daily (30 mL per day) for 7 days to 4 adult subjects with scalp and body psoriasis. At the end of treatment, the plasma cortisol levels for each of the 4 subjects remained within the normal range and changed little from baseline.
If HPA axis suppression is documented, an attempt should be made to gradually withdraw the drug, to reduce the frequency of application, or to substitute a less potent corticosteroid. Recovery of HPA axis function is generally prompt upon discontinuation of topical corticosteroids. Infrequently, signs and symptoms of glucocorticosteroid insufficiency may occur, requiring supplemental systemic corticosteroids.
Pediatric patients may be more susceptible to systemic toxicity from equivalent doses due to their larger skin surface to body mass ratios .
If irritation develops, Tinacare Lotion should be discontinued and appropriate therapy instituted. Allergic contact dermatitis with corticosteroids is usually diagnosed by observing failure to heal rather than noting a clinical exacerbation. Such an observation should be corroborated with appropriate diagnostic patch testing.
If concomitant skin infections are present or develop, an appropriate antifungal or antibacterial agent should be used. If a favorable response does not occur promptly, use of Tinacare (Mometasone Furoate) Lotion should be discontinued until the infection has been adequately controlled.
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 clinical trials involving 209 subjects, the incidence of adverse reactions associated with the use of Tinacare (Mometasone Furoate) Lotion was 3%. Reported reactions included acneiform reaction, 2; burning, 4; and itching, 1. In an irritation/sensitization study involving 156 normal subjects, the incidence of folliculitis was 3% (4 subjects).
The following adverse reactions were reported to be possibly or probably related to treatment with Tinacare (Mometasone Furoate) Lotion during a clinical trial in 14% of 65 pediatric subjects 6 months to 2 years of age: decreased glucocorticoid levels, 4; paresthesia, 2; dry mouth,1; an unspecified endocrine disorder, 1; pruritus, 1; and an unspecified skin disorder, 1. The following signs of skin atrophy were also observed among 65 subjects treated with Tinacare (Mometasone Furoate) Lotion in a clinical trial: shininess, 4; telangiectasia, 2; loss of elasticity, 2; and loss of normal skin markings, 3.
The following additional local adverse reactions have been reported with topical corticosteroids, but may occur more frequently with the use of occlusive dressings. These reactions are: irritation, dryness, hypertrichosis, hypopigmentation, perioral dermatitis, allergic contact dermatitis, secondary infection, skin atrophy, striae, and miliaria.
Most common adverse reactions included are acneiform reaction, burning, itching and folliculitis. (6)
To report SUSPECTED ADVERSE REACTIONS, contact Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., at 1-877-888-4231 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
No drug-drug interaction studies have been conducted with Tinacare (Mometasone Furoate) Lotion.
There are no adequate and well-controlled studies in pregnant women. Therefore, Tinacare Lotion should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.
Corticosteroids have been shown to be teratogenic in laboratory animals when administered systemically at relatively low dosage levels. Some corticosteroids have been shown to be teratogenic after dermal application in laboratory animals.
When administered to pregnant rats, rabbits, and mice, Tinacare (Mometasone Furoate) increased fetal malformations. The doses that produced malformations also decreased fetal growth, as measured by lower fetal weights and/or delayed ossification. Tinacare (Mometasone Furoate) also caused dystocia and related complications when administered to rats during the end of pregnancy.
In mice, Tinacare (Mometasone Furoate) caused cleft palate at subcutaneous doses of 60 mcg/kg and above. Fetal survival was reduced at 180 mcg/kg. No toxicity was observed at 20 mcg/kg. (Doses of 20, 60, and 180 mcg/kg in the mouse are approximately 0.01, 0.02, and 0.05 times the estimated maximum clinical topical dose from Tinacare (Mometasone Furoate) Lotion on a mcg/m2 basis.)
In rats, Tinacare (Mometasone Furoate) produced umbilical hernias at topical doses of 600 mcg/kg and above. A dose of 300 mcg/kg produced delays in ossification, but no malformations. (Doses of 300 and 600 mcg/kg in the rat are approximately 0.2 and 0.4 times the estimated maximum clinical topical dose from Tinacare (Mometasone Furoate) Lotion on a mcg/m2 basis.)
In rabbits, Tinacare (Mometasone Furoate) caused multiple malformations (e.g., flexed front paws, gallbladder agenesis, umbilical hernia, hydrocephaly) at topical doses of 150 mcg/kg and above (approximately 0.2 times the estimated maximum clinical topical dose from Tinacare (Mometasone Furoate) Lotion on a mcg/m2 basis). In an oral study, Tinacare (Mometasone Furoate) increased resorptions and caused cleft palate and/or head malformations (hydrocephaly and domed head) at 700 mcg/kg. At 2800 mcg/kg most litters were aborted or resorbed. No toxicity was observed at 140 mcg/kg. (Doses at 140, 700, and 2800 mcg/kg in the rabbit are approximately 0.2, 0.9, and 3.6 times the estimated maximum clinical topical dose from Tinacare (Mometasone Furoate) Lotion on a mcg/m2 basis.)
When rats received subcutaneous doses of Tinacare (Mometasone Furoate) throughout pregnancy or during the later stages of pregnancy, 15 mcg/kg caused prolonged and difficult labor and reduced the number of live births, birth weight, and early pup survival. Similar effects were not observed at 7.5 mcg/kg. (Doses of 7.5 and 15 mcg/kg in the rat are approximately 0.005 and 0.01 times the estimated maximum clinical topical dose from Tinacare (Mometasone Furoate) Lotion on a mcg/m2 basis.)
Systemically administered corticosteroids appear in human milk and could suppress growth, interfere with endogenous corticosteroid production, or cause other untoward effects. It is not known whether topical administration of corticosteroids could result in sufficient systemic absorption to produce detectable quantities in human milk. Because many drugs are excreted in human milk, caution should be exercised when Tinacare (Mometasone Furoate) Lotion is administered to a nursing woman.
Since safety and efficacy of Tinacare Lotion have not been established in pediatric patients below 12 years of age, its use in this age group is not recommended.
Tinacare (Mometasone Furoate) Lotion caused HPA axis suppression in approximately 29% of pediatric subjects ages 6 to 23 months, who showed normal adrenal function by Cortrosyn test before starting treatment, and were treated for approximately 3 weeks over a mean body surface area of 40% (range 16%-90%). The criteria for suppression were: basal cortisol level of ≤5 mcg/dL, 30-minute post-stimulation level of ≤18 mcg/dL, or an increase of <7 mcg/dL. Follow-up testing 2 to 4 weeks after stopping treatment, available for 8 of the subjects, demonstrated suppressed HPA axis function in 1 subject, using these same criteria. Long-term use of topical corticosteroids has not been studied in this population .
Because of a higher ratio of skin surface area to body mass, pediatric patients are at a greater risk than adults of HPA axis suppression and Cushing's syndrome when they are treated with topical corticosteroids. They are, therefore, also at greater risk of adrenal insufficiency during and/or after withdrawal of treatment. Pediatric patients may be more susceptible than adults to skin atrophy, including striae, when they are treated with topical corticosteroids. Pediatric patients applying topical corticosteroids to greater than 20% of body surface are at higher risk of HPA axis suppression.
HPA axis suppression, Cushing's syndrome, linear growth retardation, delayed weight gain, and intracranial hypertension have been reported in pediatric patients receiving topical corticosteroids. Manifestations of adrenal suppression in children include low plasma cortisol levels and absence of response to ACTH stimulation. Manifestations of intracranial hypertension include bulging fontanelles, headaches, and bilateral papilledema.
Tinacare (Mometasone Furoate) Lotion should not be used in the treatment of diaper dermatitis.
Clinical trials of Tinacare (Mometasone Furoate) Lotion did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. Other 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 usually starting at the low end of the dosing range.
Topically applied Tinacare (Mometasone Furoate) Lotion can be absorbed in sufficient amounts to produce systemic effects .
Tinacare (Mometasone Furoate) (mometasone furoate) Lotion, 0.1% contains Tinacare (Mometasone Furoate) for topical use. Tinacare (Mometasone Furoate) is a synthetic corticosteroid with anti-inflammatory activity.
Chemically, Tinacare (Mometasone Furoate) is 9α, 21-dichloro-11β,17-dihydroxy-16α-methylpregna-1,4-diene-3,20-dione 17-(2-furoate), with the empirical formula C27H30Cl2O6, a molecular weight of 521.4 and the following structural formula:
Tinacare (Mometasone Furoate) is a white to off-white powder practically insoluble in water, slightly soluble in octanol, and moderately soluble in ethyl alcohol.
Each gram of Tinacare (Mometasone Furoate) Lotion, 0.1% contains 1 mg Tinacare (Mometasone Furoate) in a colorless, clear to translucent lotion base of hydroxypropyl cellulose, isopropyl alcohol (40%), propylene glycol, purified water and sodium phosphate monobasic monohydrate. May also contain phosphoric acid used to adjust the pH to approximately 4.5.
Like other topical corticosteroids, Tinacare has anti-inflammatory, antipruritic, and vasoconstrictive properties. The mechanism of the anti-inflammatory activity of the topical steroids, in general, is unclear. However, corticosteroids are thought to act by the induction of phospholipase A2 inhibitory proteins, collectively called lipocortins. It is postulated that these proteins control the biosynthesis of potent mediators of inflammation such as prostaglandins and leukotrienes by inhibiting the release of their common precursor arachidonic acid. Arachidonic acid is released from membrane phospholipids by phospholipase A2.
Studies performed with Tinacare (Mometasone Furoate) Lotion indicate that it is in the medium range of potency as compared with other topical corticosteroids.
In a study evaluating the effects of Tinacare (Mometasone Furoate) lotion on the HPA axis, 15 mL were applied without occlusion twice daily (30 mL per day) for 7 days to 4 adult subjects with scalp and body psoriasis. At the end of treatment, the plasma cortisol levels for each of the 4 subjects remained within the normal range and changed little from baseline .
Sixty-five pediatric subjects ages 6 to 23 months, with atopic dermatitis, were enrolled in an open-label, HPA axis safety trial. Tinacare (Mometasone Furoate) Lotion was applied once daily for approximately 3 weeks over a mean body surface area of 40% (range 16%-90%). In approximately 29% of subjects who showed normal adrenal function by Cortrosyn test before starting treatment, adrenal suppression was observed at the end of treatment with Tinacare (Mometasone Furoate) Lotion. The criteria for suppression were: basal cortisol level of ≤5 mcg/dL, 30-minute post-stimulation level of ≤18 mcg/dL, or an increase of <7 mcg/dL. Follow-up testing 2 to 4 weeks after stopping treatment, available for 8 of the subjects, demonstrated suppressed HPA axis function in 1 subject, using these same criteria [ see Use in Specific Populations (8.4)].
The extent of percutaneous absorption of topical corticosteroids is determined by many factors including the vehicle and the integrity of the epidermal barrier. Studies in humans indicate that approximately 0.7% of the applied dose of Tinacare (Mometasone Furoate) Ointment enters the circulation after 8 hours of contact on normal skin without occlusion. A similar minimal degree of absorption of the corticosteroid from the lotion formulation would be anticipated. Inflammation and/or other disease processes in the skin may increase percutaneous absorption.
Long-term animal studies have not been performed to evaluate the carcinogenic potential of Tinacare (Mometasone Furoate) Lotion. Long-term carcinogenicity studies of Tinacare (Mometasone Furoate) were conducted by the inhalation route in rats and mice. In a 2-year carcinogenicity study in Sprague Dawley rats, Tinacare (Mometasone Furoate) demonstrated no statistically significant increase of tumors at inhalation doses up to 67 mcg/kg (approximately 0.04 times the estimated maximum clinical topical dose from Tinacare (Mometasone Furoate) Lotion on a mcg/m2 basis). In a 19-month carcinogenicity study in Swiss CD-1 mice, Tinacare (Mometasone Furoate) demonstrated no statistically significant increase in the incidence of tumors at inhalation doses up to 160 mcg/kg (approximately 0.05 times the estimated maximum clinical topical dose from Tinacare (Mometasone Furoate) Lotion on a mcg/m2 basis).
Tinacare (Mometasone Furoate) increased chromosomal aberrations in an in vitro Chinese hamster ovary cell assay, but did not increase chromosomal aberrations in an in vitro Chinese hamster lung cell assay. Tinacare (Mometasone Furoate) was not mutagenic in the Ames test or mouse lymphoma assay, and was not clastogenic in an in vivo mouse micronucleus assay, a rat bone marrow chromosomal aberration assay, or a mouse male germ-cell chromosomal aberration assay. Tinacare (Mometasone Furoate) also did not induce unscheduled DNA synthesis in vivo in rat hepatocytes.
In reproductive studies in rats, impairment of fertility was not produced in male or female rats by subcutaneous doses up to 15 mcg/kg (approximately 0.01 times the estimated maximum clinical topical dose from Tinacare (Mometasone Furoate) Lotion on a mcg/m2 basis).
The safety and efficacy of Tinacare (Mometasone Furoate) Lotion, 0.1% for the treatment of corticosteroid-responsive dermatoses was demonstrated in two vehicle-controlled trials, one in scalp psoriasis and one in seborrheic dermatitis. A total of 405 subjects (age range: 12-95 years) received Tinacare (Mometasone Furoate) Lotion (205 subjects) or the vehicle lotion applied once daily for 21 days.
Tinacare (Mometasone Furoate) Lotion is colorless, clear to translucent and supplied in 30-mL (27.5 gram) (NDC 0085-0854-01) and 60-mL (55 gram) (NDC 0085-0854-02) bottles; boxes of one.
Store Tinacare (Mometasone Furoate) Lotion, 0.1% at 25°C (77°F); excursions permitted to 15-30°C (59-86°F).
Inform patients of the following:
Manufactured for: Merck Sharp & Dohme Corp., a subsidiary of
MERCK & CO., INC., Whitehouse Station, NJ 08889, USA
Manufactured by: Bayer Inc.
Pointe Claire, Quebec H9R 1B4, Canada
For patent information: www.merck.com/product/patent/home.html
Copyright © 1989, 2008, 2012 Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.
All rights reserved.
PRINCIPAL DISPLAY PANEL - 30 mL Bottle Carton
30 mL (27.5 g)
Tinacare (Mometasone Furoate)®
DO NOT USE IN EYES
PRINCIPAL DISPLAY PANEL - 30 mL Bottle Carton
Tinacare (Tretinoin) is a topical form of vitamin A. This vitamin is known for its ability to help the skin gradually renew itself. This medicine is mostly used in the treatment of acne, but it is sometimes prescribed to reduce the appearance of mottled skin discoloration and fine wrinkles (to make the patient's facial skin from rough to smooth and silky).
Tinacare (Tretinoin) is a popular topical form of vitamin A that has proven itself to be highly effective in the treatment of acne. However, this medicine might also be used to treat or to prevent the appearance of some other medical disorders that have not been listed here.
Tinacare (Tretinoin) is a category C FDA pregnancy drug. Therefore, using this medicine during pregnancy could harm a growing fetus. Before you start a treatment with this medicine, you must inform your personal physician if you are pregnant or if you are planning to be so soon. It has been determined that this medicine's main ingredients are able to pass into breastmilk. Ask your personal physician if it is safe to start using Tinacare (Tretinoin) if you are currently nursing an infant.
During your treatment with Tinacare (Tretinoin) you should avoid prolonged and unprotected exposure to artificial UV rays (tanning beds or sunlamps) or to direct sunlight. A treatment with this medicine is known to increase the patient's skin's sensitivity to direct sunlight, thus leading to severe sunburn. However, if you cannot avoid exposure to sunlight, sunlamps or tanning beds, you must use an effective sunscreen (at least SPF 15). It is recommended that you should wear protective clothing. Avoid letting this medication get in direct contact with your eyes, nose, mouth or with your lips. However, if a small amount of this medicine somehow gets into contact with any of the areas that have been listed here, you should wash it with plenty of water.
You must avoid using Tinacare (Tretinoin) on windburned, sunburned, irritated, chapped, or broken skin or on skin areas that are suffering from any forms of Eczema. If you do have any of these medical conditions you should first wait for them to heal before you consider using this medicine. Do not stop your treatment with Tinacare (Tretinoin) without your physician's approval even if you start to feel better after a few days of treatment (in some cases, the symptoms improve even if the infection has not completely healed). Some patients have to use this medicine for several months before they can finally see the results of their treatment. If you have been prescribed this drug to treat acne, your skin condition might worsen for a short period of time at the beginning of the treatment. If this persists for more than 12 weeks or if your medical condition has not improved after 3 months of treatment you must alert your personal physician.
You ought to use this drug exactly how your personal doctor has prescribed you to. You can consult the medicine's label if you want to get further information. If you fail to understand some of the physician's instructions, you should contact a pharmacist, a nurse or a doctor and ask them to explain them to you. Using a higher dose of this medicine or applying the drug more often than your personal physician has prescribed you to, will not make the results appear faster (it might increase this Acta's unpleasant side effects). You must wash both your hands after and before you apply Tinacare (Tretinoin). Before you apply the medicine you should make sure that the skin area that you are about to treat is both clean and dry. Applying this medicine on a wet skin area can sometimes cause skin irritation.
You must not wash the skin area that you have treated with Tinacare (Tretinoin) for at least 60 minutes after applying the medicine. Avoid using any other type of skin products on the skin area that you have treated with this drug for at least 1 hour after using this drug topical. This medicine should be stored in a cool and dry place, away from heat, moisture and direct sunlight. Keep it in a place that is far from the reach of pets and children in order to avoid unwanted accidents such as poisoning. This medicine is highly flammable. Keep the drug container away from any open flame.
Ask your personal physician to calculate the dose of this medicine that works best for your condition. Do not make any alterations to the dose of Tinacare (Tretinoin) that you have been prescribed without your physician's approval.
If you suspect that you are suffering from an overdose with this medicine, you are probably in need of emergency medical care. Contact your local poison control center and your personal physician as soon as you can. An overdose with this medicine should not trigger any unpleasant symptoms.
In order to get the most benefits from your treatment with Tinacare (Tretinoin) you should take it on a regular basis. If you miss one of your prescribed doses of this medicine you should take it as soon as you remember. If it is already time for another prescribed dose, skip the one that you have missed and proceed with your regular treatment. Avoid using extra doses of this medicine without first consulting it with your personal physician.
Alert your doctor if you experience anything bothersome during your treatment with Tinacare (Tretinoin).
Ask your personal physician if it is safe to take any other medicines while using Tinacare (Tretinoin).
Depending on the reaction of the Tinacare after taken, if you are feeling dizziness, drowsiness or any weakness as a reaction on your body, Then consider Tinacare 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 Tinacare 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