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calcipotriene and betamethasone dipropionate
Overview
What is ENSTILAR?
Enstilar Foam contains calcipotriene hydrate and betamethasone dipropionate. It is intended for topical use only.
Calcipotriene hydrate is a synthetic vitamin D analog.
Chemically, calcipotriene hydrate is 9,10-secochola-5,7,10(19),22-tetraene-1,3,24-triol,24-cyclo-propyl-,monohydrate, (1α,3ß,5Z,7E,22E,24S) with the empirical formula CHO,HO, a molecular weight of 430.6, and the following structural formula:
Calcipotriene hydrate is a white to almost white, crystalline compound.
Betamethasone dipropionate is a synthetic corticosteroid.
Betamethasone dipropionate has the chemical name pregna-1,4-diene-3,20-dione-9-fluoro-11-hydroxy-16-methyl-17,21-bis(1-oxypropoxy)-(11β,16β), with the empirical formula CHFO, a molecular weight of 504.6, and the following structural formula:
Betamethasone dipropionate is a white to almost white crystalline powder.
Enstilar Foam is a white to off-white opalescent liquid in a pressurized aluminum spray can with a continuous valve and actuator. The propellants used in Enstilar Foam are dimethyl ether and butane. At administration the product is a white to off-white foam after evaporation of the propellants. Each gram of Enstilar Foam contains 52.2 mcg calcipotriene hydrate (equivalent to 50 mcg of calcipotriene) and 0.643 mg of betamethasone dipropionate (equivalent to 0.5 mg of betamethasone) in a base of white petrolatum, polyoxypropylene stearyl ether, mineral oil, all-rac-alpha-tocopherol, and butylhydroxytoluene.
What does ENSTILAR look like?
What are the available doses of ENSTILAR?
Foam, 0.005%/0.064%
Each gram of Enstilar Foam contains 52.2 mcg calcipotriene hydrate (equivalent to 50 mcg of calcipotriene) and 0.643 mg of betamethasone dipropionate (equivalent to 0.5 mg of betamethasone).
What should I talk to my health care provider before I take ENSTILAR?
How should I use ENSTILAR?
Enstilar (calcipotriene and betamethasone dipropionate) Foam is indicated for the topical treatment of plaque psoriasis in patients 18 years of age and older.
Instruct patients to shake can prior to using Enstilar Foam and to wash their hands after applying the product.
Apply Enstilar Foam to affected areas once daily for up to 4 weeks. Rub in Enstilar Foam gently. Discontinue use when control is achieved.
Instruct patients not to use more than 60 g every 4 days.
Enstilar Foam should not be used with occlusive dressings unless directed by a physician. Enstilar Foam is not for oral, ophthalmic, or intravaginal use.
Avoid use on the face, groin, or axillae, or if skin atrophy is present at the treatment site.
What interacts with ENSTILAR?
Sorry No Records found
What are the warnings of ENSTILAR?
Sorry No Records found
What are the precautions of ENSTILAR?
Sorry No Records found
What are the side effects of ENSTILAR?
Sorry No records found
What should I look out for while using ENSTILAR?
None.
What might happen if I take too much ENSTILAR?
Sorry No Records found
How should I store and handle ENSTILAR?
Store olanzapine tablets at 20°C to 25°C (68°F to 77°F); excursions permitted from 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature].Protect olanzapine tablets from light and moisture. Store olanzapine tablets at 20°C to 25°C (68°F to 77°F); excursions permitted from 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature].Protect olanzapine tablets from light and moisture. Each LUPRON DEPOT 7.5 mg for 1-month administration kit (NDC 0074-3642-03), 22.5 mg for 3-month administration kit (NDC 0074-3346-03), 30 mg for 4-month administration kit (NDC 0074-3683-03), 45 mg for 6-month administration kit (NDC 0074-3473-03) contains:The prefilled dual-chamber syringe of LUPRON DEPOT 7.5 mg for 1-month administration contains sterile lyophilized microspheres of leuprolide acetate incorporated in a biodegradable lactic acid/glycolic acid copolymer. The prefilled dual-chamber syringe of LUPRON DEPOT 22.5 mg for 3-month administration, 30 mg for 4-month administration, 45 mg for 6-month administration contains sterile lyophilized microspheres of leuprolide acetate incorporated in a biodegradable lactic acid polymer.When mixed with 1 mL of accompanying diluent, LUPRON DEPOT 7.5 mg for 1-month administration is administered as a single monthly intramuscular injection.When mixed with 1.5 mL of accompanying diluent, LUPRON DEPOT 22.5 mg for 3-month administration is administered as a single intramuscular injection .When mixed with 1.5 mL of accompanying diluent, LUPRON DEPOT 30 mg for 4-month administration is administered as a single intramuscular injection .When mixed with 1.5 mL of accompanying diluent, LUPRON DEPOT 45 mg for 6-month administration is administered as a single intramuscular injection .Store at 25°C (77°F); excursions permitted to 15°C–30°C (59°F–86°F) [See USP Controlled Room Temperature].Each LUPRON DEPOT 7.5 mg for 1-month administration kit (NDC 0074-3642-03), 22.5 mg for 3-month administration kit (NDC 0074-3346-03), 30 mg for 4-month administration kit (NDC 0074-3683-03), 45 mg for 6-month administration kit (NDC 0074-3473-03) contains:The prefilled dual-chamber syringe of LUPRON DEPOT 7.5 mg for 1-month administration contains sterile lyophilized microspheres of leuprolide acetate incorporated in a biodegradable lactic acid/glycolic acid copolymer. The prefilled dual-chamber syringe of LUPRON DEPOT 22.5 mg for 3-month administration, 30 mg for 4-month administration, 45 mg for 6-month administration contains sterile lyophilized microspheres of leuprolide acetate incorporated in a biodegradable lactic acid polymer.When mixed with 1 mL of accompanying diluent, LUPRON DEPOT 7.5 mg for 1-month administration is administered as a single monthly intramuscular injection.When mixed with 1.5 mL of accompanying diluent, LUPRON DEPOT 22.5 mg for 3-month administration is administered as a single intramuscular injection .When mixed with 1.5 mL of accompanying diluent, LUPRON DEPOT 30 mg for 4-month administration is administered as a single intramuscular injection .When mixed with 1.5 mL of accompanying diluent, LUPRON DEPOT 45 mg for 6-month administration is administered as a single intramuscular injection .Store at 25°C (77°F); excursions permitted to 15°C–30°C (59°F–86°F) [See USP Controlled Room Temperature].Each LUPRON DEPOT 7.5 mg for 1-month administration kit (NDC 0074-3642-03), 22.5 mg for 3-month administration kit (NDC 0074-3346-03), 30 mg for 4-month administration kit (NDC 0074-3683-03), 45 mg for 6-month administration kit (NDC 0074-3473-03) contains:The prefilled dual-chamber syringe of LUPRON DEPOT 7.5 mg for 1-month administration contains sterile lyophilized microspheres of leuprolide acetate incorporated in a biodegradable lactic acid/glycolic acid copolymer. The prefilled dual-chamber syringe of LUPRON DEPOT 22.5 mg for 3-month administration, 30 mg for 4-month administration, 45 mg for 6-month administration contains sterile lyophilized microspheres of leuprolide acetate incorporated in a biodegradable lactic acid polymer.When mixed with 1 mL of accompanying diluent, LUPRON DEPOT 7.5 mg for 1-month administration is administered as a single monthly intramuscular injection.When mixed with 1.5 mL of accompanying diluent, LUPRON DEPOT 22.5 mg for 3-month administration is administered as a single intramuscular injection .When mixed with 1.5 mL of accompanying diluent, LUPRON DEPOT 30 mg for 4-month administration is administered as a single intramuscular injection .When mixed with 1.5 mL of accompanying diluent, LUPRON DEPOT 45 mg for 6-month administration is administered as a single intramuscular injection .Store at 25°C (77°F); excursions permitted to 15°C–30°C (59°F–86°F) [See USP Controlled Room Temperature].Each LUPRON DEPOT 7.5 mg for 1-month administration kit (NDC 0074-3642-03), 22.5 mg for 3-month administration kit (NDC 0074-3346-03), 30 mg for 4-month administration kit (NDC 0074-3683-03), 45 mg for 6-month administration kit (NDC 0074-3473-03) contains:The prefilled dual-chamber syringe of LUPRON DEPOT 7.5 mg for 1-month administration contains sterile lyophilized microspheres of leuprolide acetate incorporated in a biodegradable lactic acid/glycolic acid copolymer. The prefilled dual-chamber syringe of LUPRON DEPOT 22.5 mg for 3-month administration, 30 mg for 4-month administration, 45 mg for 6-month administration contains sterile lyophilized microspheres of leuprolide acetate incorporated in a biodegradable lactic acid polymer.When mixed with 1 mL of accompanying diluent, LUPRON DEPOT 7.5 mg for 1-month administration is administered as a single monthly intramuscular injection.When mixed with 1.5 mL of accompanying diluent, LUPRON DEPOT 22.5 mg for 3-month administration is administered as a single intramuscular injection .When mixed with 1.5 mL of accompanying diluent, LUPRON DEPOT 30 mg for 4-month administration is administered as a single intramuscular injection .When mixed with 1.5 mL of accompanying diluent, LUPRON DEPOT 45 mg for 6-month administration is administered as a single intramuscular injection .Store at 25°C (77°F); excursions permitted to 15°C–30°C (59°F–86°F) [See USP Controlled Room Temperature].Each LUPRON DEPOT 7.5 mg for 1-month administration kit (NDC 0074-3642-03), 22.5 mg for 3-month administration kit (NDC 0074-3346-03), 30 mg for 4-month administration kit (NDC 0074-3683-03), 45 mg for 6-month administration kit (NDC 0074-3473-03) contains:The prefilled dual-chamber syringe of LUPRON DEPOT 7.5 mg for 1-month administration contains sterile lyophilized microspheres of leuprolide acetate incorporated in a biodegradable lactic acid/glycolic acid copolymer. The prefilled dual-chamber syringe of LUPRON DEPOT 22.5 mg for 3-month administration, 30 mg for 4-month administration, 45 mg for 6-month administration contains sterile lyophilized microspheres of leuprolide acetate incorporated in a biodegradable lactic acid polymer.When mixed with 1 mL of accompanying diluent, LUPRON DEPOT 7.5 mg for 1-month administration is administered as a single monthly intramuscular injection.When mixed with 1.5 mL of accompanying diluent, LUPRON DEPOT 22.5 mg for 3-month administration is administered as a single intramuscular injection .When mixed with 1.5 mL of accompanying diluent, LUPRON DEPOT 30 mg for 4-month administration is administered as a single intramuscular injection .When mixed with 1.5 mL of accompanying diluent, LUPRON DEPOT 45 mg for 6-month administration is administered as a single intramuscular injection .Store at 25°C (77°F); excursions permitted to 15°C–30°C (59°F–86°F) [See USP Controlled Room Temperature].Each LUPRON DEPOT 7.5 mg for 1-month administration kit (NDC 0074-3642-03), 22.5 mg for 3-month administration kit (NDC 0074-3346-03), 30 mg for 4-month administration kit (NDC 0074-3683-03), 45 mg for 6-month administration kit (NDC 0074-3473-03) contains:The prefilled dual-chamber syringe of LUPRON DEPOT 7.5 mg for 1-month administration contains sterile lyophilized microspheres of leuprolide acetate incorporated in a biodegradable lactic acid/glycolic acid copolymer. The prefilled dual-chamber syringe of LUPRON DEPOT 22.5 mg for 3-month administration, 30 mg for 4-month administration, 45 mg for 6-month administration contains sterile lyophilized microspheres of leuprolide acetate incorporated in a biodegradable lactic acid polymer.When mixed with 1 mL of accompanying diluent, LUPRON DEPOT 7.5 mg for 1-month administration is administered as a single monthly intramuscular injection.When mixed with 1.5 mL of accompanying diluent, LUPRON DEPOT 22.5 mg for 3-month administration is administered as a single intramuscular injection .When mixed with 1.5 mL of accompanying diluent, LUPRON DEPOT 30 mg for 4-month administration is administered as a single intramuscular injection .When mixed with 1.5 mL of accompanying diluent, LUPRON DEPOT 45 mg for 6-month administration is administered as a single intramuscular injection .Store at 25°C (77°F); excursions permitted to 15°C–30°C (59°F–86°F) [See USP Controlled Room Temperature].Each LUPRON DEPOT 7.5 mg for 1-month administration kit (NDC 0074-3642-03), 22.5 mg for 3-month administration kit (NDC 0074-3346-03), 30 mg for 4-month administration kit (NDC 0074-3683-03), 45 mg for 6-month administration kit (NDC 0074-3473-03) contains:The prefilled dual-chamber syringe of LUPRON DEPOT 7.5 mg for 1-month administration contains sterile lyophilized microspheres of leuprolide acetate incorporated in a biodegradable lactic acid/glycolic acid copolymer. The prefilled dual-chamber syringe of LUPRON DEPOT 22.5 mg for 3-month administration, 30 mg for 4-month administration, 45 mg for 6-month administration contains sterile lyophilized microspheres of leuprolide acetate incorporated in a biodegradable lactic acid polymer.When mixed with 1 mL of accompanying diluent, LUPRON DEPOT 7.5 mg for 1-month administration is administered as a single monthly intramuscular injection.When mixed with 1.5 mL of accompanying diluent, LUPRON DEPOT 22.5 mg for 3-month administration is administered as a single intramuscular injection .When mixed with 1.5 mL of accompanying diluent, LUPRON DEPOT 30 mg for 4-month administration is administered as a single intramuscular injection .When mixed with 1.5 mL of accompanying diluent, LUPRON DEPOT 45 mg for 6-month administration is administered as a single intramuscular injection .Store at 25°C (77°F); excursions permitted to 15°C–30°C (59°F–86°F) [See USP Controlled Room Temperature].Each LUPRON DEPOT 7.5 mg for 1-month administration kit (NDC 0074-3642-03), 22.5 mg for 3-month administration kit (NDC 0074-3346-03), 30 mg for 4-month administration kit (NDC 0074-3683-03), 45 mg for 6-month administration kit (NDC 0074-3473-03) contains:The prefilled dual-chamber syringe of LUPRON DEPOT 7.5 mg for 1-month administration contains sterile lyophilized microspheres of leuprolide acetate incorporated in a biodegradable lactic acid/glycolic acid copolymer. The prefilled dual-chamber syringe of LUPRON DEPOT 22.5 mg for 3-month administration, 30 mg for 4-month administration, 45 mg for 6-month administration contains sterile lyophilized microspheres of leuprolide acetate incorporated in a biodegradable lactic acid polymer.When mixed with 1 mL of accompanying diluent, LUPRON DEPOT 7.5 mg for 1-month administration is administered as a single monthly intramuscular injection.When mixed with 1.5 mL of accompanying diluent, LUPRON DEPOT 22.5 mg for 3-month administration is administered as a single intramuscular injection .When mixed with 1.5 mL of accompanying diluent, LUPRON DEPOT 30 mg for 4-month administration is administered as a single intramuscular injection .When mixed with 1.5 mL of accompanying diluent, LUPRON DEPOT 45 mg for 6-month administration is administered as a single intramuscular injection .Store at 25°C (77°F); excursions permitted to 15°C–30°C (59°F–86°F) [See USP Controlled Room Temperature].
Clinical Information
Chemical Structure
No Image foundClinical Pharmacology
Enstilar Foam combines the pharmacological effects of calcipotriene hydrate as a synthetic vitamin D analog and betamethasone dipropionate as a synthetic corticosteroid. However, while their pharmacologic and clinical effects are known, the exact mechanisms of their actions in plaque psoriasis are unknown.
Non-Clinical Toxicology
None.Inhibitors of CYP3A4 and CYP2D6
The concomitant use of Oxycodone and Acetaminophen Tablets and CYP3A4 inhibitors, such as macrolide antibiotics (e.g., erythromycin), azole-antifungal agents (e.g., ketoconazole), and protease inhibitors (e.g., ritonavir), can increase the plasma concentration of oxycodone, resulting in increased or prolonged opioid effects. These effects could be more pronounced with concomitant use of Oxycodone and Acetaminophen Tablets and CYP3A4 and CYP2D6 inhibitors, particularly when an inhibitor is added after a stable dose of Oxycodone and Acetaminophen Tablets is achieved [see ].
After stopping a CYP3A4 inhibitor, as the effects of the inhibitor decline, the oxycodone plasma concentration will decrease [see ], resulting in decreased opioid efficacy or a withdrawal syndrome in patients who had developed physical dependence to Oxycodone and Acetaminophen Tablets.
If concomitant use is necessary, consider dosage reduction of Oxycodone and Acetaminophen Tablets until stable drug effects are achieved. Monitor patients for respiratory depression and sedation at frequent intervals. If a CYP3A4 inhibitor is discontinued, consider increasing the Oxycodone and Acetaminophen Tablets dosage until stable drug effects are achieved. Monitor for signs of opioid withdrawal.
Inducers of CYP3A4
The concomitant use of Oxycodone and Acetaminophen Tablets and CYP3A4 inducers, such as rifampin, carbamazepine, and phenytoin, can decrease the plasma concentration of oxycodone [see ], resulting in decreased efficacy or onset of a withdrawal syndrome in patients who have developed physical dependence to Oxycodone and Acetaminophen Tablets [see ].
After stopping a CYP3A4 inducer, as the effects of the inducer decline, the oxycodone plasma concentration will increase [see ], which could increase or prolong both the therapeutic effects and adverse reactions, and may cause serious respiratory depression.
If concomitant use is necessary, consider increasing the Oxycodone and Acetaminophen Tablets dosage until stable drug effects are achieved. Monitor for signs of opioid withdrawal. If a CYP3A4 inducer is discontinued, consider Oxycodone and Acetaminophen Tablets dosage reduction and monitor for signs of respiratory depression.
Benzodiazepines and Other (CNS) Depressants
Due to additive pharmacologic effect, the concomitant use of benzodiazepines and other CNS depressants such as benzodiazepines and other sedative hypnotics, anxiolytics, and tranquilizers, muscle relaxants, general anesthetics, antipsychotics, and other opioids, including alcohol, can increase the risk of hypotension, respiratory depression, profound sedation, coma, and death.
Reserve concomitant prescribing of these drugs for use in patients for whom alternative treatment options are inadequate. Limit dosages and durations to the minimum required. Follow patients closely for signs of respiratory depression and sedation [see ].
Serotonergic Drugs
The concomitant use of opioids with other drugs that affect the serotonergic neurotransmitter system, such as selective serotonin reuptake inhibitors (SSRIs), serotonin and norepinephrine reuptake inhibitors (SNRIs), tricyclic antidepressants (TCAs), tryptans, 5-HT3 receptor antagonists, drugs that affect the serotonin neurotransmitter system (e.g., mirtazapine, trazodone, tramadol), and monoamine oxidase (MAO) inhibitors (those intended to treat psychiatric disorders and also others, such as linezolid and intravenous methylene blue), has resulted in serotonin syndrome [see ].
If concomitant use is warranted, carefully observe the patient, particularly during treatment initiation and dose adjustment. Discontinue Oxycodone and Acetaminophen Tablets if serotonin syndrome is suspected.
Monoamine Oxidase Inhibitors (MAOIs)
The concomitant use of opioids and MAOIs, such as phenelzine, tranylcypromine, linezolid, may manifest as serotonin syndrome or opioid toxicity (e.g., respiratory depression, coma) [see ].
The use of Oxycodone and Acetaminophen Tablets is not recommended for patients taking MAOIs or within 14 days of stopping such treatment.
If urgent use of an opioid is necessary, use test doses and frequent titration of small doses to treat pain while closely monitoring blood pressure and signs and symptoms of CNS and respiratory depression.
The concomitant use of opioids with other opioid analgesics, such as butorphanol, nalbuphine, pentazocine, may reduce the analgesic effect of Oxycodone and Acetaminophen Tablets and/or precipitate withdrawal symptoms.
Advise patient to avoid concomitant use of these drugs.
Muscle Relaxants
Oxycodone and Acetaminophen Tablets may enhance the neuromuscular-blocking action of skeletal muscle relaxants and produce an increase in the degree of respiratory depression.
If concomitant use is warranted, monitor patients for signs of respiratory depression that may be greater than otherwise expected and decrease the dosage of Oxycodone and Acetaminophen Tablets and/or the muscle relaxant as necessary.
Diuretics
Opioids can reduce the efficacy of diuretics by inducing the release of antidiuretic hormone.
If concomitant use is warranted, monitor patients for signs of diminished diuresis and/or effects on blood pressure and increase the dosage of the diuretic as needed.
Anticholinergic Drugs
The concomitant use of anticholinergic drugs may increase risk of urinary retention and/or severe constipation, which may lead to paralytic ileus.
If concomitant use is warranted, monitor patients for signs of urinary retention or reduced gastric motility when Oxycodone and Acetaminophen Tablets are used concomitantly with anticholinergic drugs.
Alcohol, ethyl
Hepatotoxicity has occurred in chronic alcoholics following various dose levels (moderate to excessive) of acetaminophen.
Oral Contraceptives
Increase in glucuronidation resulting in increased plasma clearance and a decreased half-life of acetaminophen.
Charcoal (activated)
Reduces acetaminophen absorption when administered as soon as possible after overdose.
Beta Blockers (Propranolol)
Propranolol appears to inhibit the enzyme systems responsible for the glucuronidation and oxidation of acetaminophen. Therefore, the pharmacologic effects of acetaminophen may be increased.
The effects of the loop diuretic may be decreased because acetaminophen may decrease renal prostaglandin excretion and decrease plasma renin activity.
Lamotrigine
Serum lamotrigine concentrations may be reduced, producing a decrease in therapeutic effects.
Probenecid
Probenecid may increase the therapeutic effectiveness of acetaminophen slightly.
Zidovudine
The pharmacologic effects of zidovudine may be decreased because of enhanced non-hepatic or renal clearance of zidovudine.
The propellants in Enstilar Foam are flammable. Instruct the patient to avoid fire, flame, and smoking during and immediately following application.
Reference
This information is obtained from the National Institute of Health's Standard Packaging Label drug database.
"https://dailymed.nlm.nih.gov/dailymed/"
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Clonazepam Description Each single-scored tablet, for oral administration, contains 0.5 mg, 1 mg, or 2 mg Clonazepam, USP, a benzodiazepine. Each tablet also contains corn starch, lactose monohydrate, magnesium stearate, microcrystalline cellulose, and povidone. Clonazepam tablets USP 0.5 mg contain Yellow D&C No. 10 Aluminum Lake. Clonazepam tablets USP 1 mg contain Yellow D&C No. 10 Aluminum Lake, as well as FD&C Blue No. 1 Aluminum Lake. Chemically, Clonazepam, USP is 5-(o-chlorophenyl)-1,3-dihydro-7-nitro-2H-1,4-benzodiazepin-2-one. It is a light yellow crystalline powder. It has the following structural formula: C15H10ClN3O3 M.W. 315.72Tips
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