Top Articles Directory Bangladesh: 2016

Tuesday, October 25, 2016

Ambrisentan

Class: Vasodilating Agents, Miscellaneous
VA Class: CV900
Chemical Name: (+)-(2S)-2-[(4,6-Diamethylpyrimidin-2-yl)oxy]-3-methoxy-3,3-diphenylpropanoic acid
Molecular Formula: C₂₂H₂₂N₂O₄
CAS Number: 177036-94-1
Brands: Letairis

Hepatotoxicity

Potential risk of developing hepatic injury.¹ ³ ¹⁸ Elevated serum aminotransferase (AST/ALT) concentrations to at least 3 times the upper limit of normal (ULN) reported.¹ ⁹ A class effect of endothelin-receptor antagonists;¹ ⁶ ¹⁰ ¹¹ ¹⁴ during postmarketing experience, unexplained hepatic cirrhosis and liver failure reported rarely after prolonged therapy (>12 months) with another endothelin-receptor antagonist (bosentan).¹ ⁶

Serum aminotransferases and bilirubin (if aminotransferase concentrations are elevated)³ must be measured prior to initiation of therapy and monthly thereafter.¹ (See Hepatic Effects under Cautions.)

In patients with adverse hepatic effects, dosage reduction, interruption of therapy, or discontinuance of the drug may be necessary.¹ ³ (See Patients with Adverse Hepatic Effects under Dosage and Administration.)

Ambrisentan generally should be avoided in patients with elevated aminotransferases (>3 × ULN) at baseline (because monitoring for liver injury may be more difficult).¹

Fetotoxicity

May cause fetal harm; contraindicated in pregnant women.¹ ¹⁸ Pregnancy must be excluded before start of treatment and prevented thereafter by use of 2 acceptable methods of contraception during and for one month following treatment unless patient has undergone tubal sterilization or chooses to use a Copper T380A or LNg 20 IUD, in which case no additional contraceptive method is required.¹ ³ ¹⁸ (See Fetal/Neonatal Morbidity and Mortality under Cautions and also see Advice to Patients.)

REMS:

FDA approved a REMS for ambrisentan to ensure that the benefits of a drug outweigh the risks. The REMS may apply to one or more preparations of ambrisentan and consists of the following: medication guide, elements to assure safe use, and implementation system. See the FDA REMS page () or the ASHP REMS Resource Center ().

Introduction

Vasodilator; a propionic-acid,² ³ ¹² ¹⁴ ¹⁷ endothelin-1 (ET-1) type A receptor-selective antagonist.¹ ² ⁴ ⁹ ¹² ¹⁴

Uses for Ambrisentan

Pulmonary Arterial Hypertension

Treatment of pulmonary arterial hypertension (PAH), WHO group 1, in patients with WHO class II or III symptoms to improve exercise capacity and to delay clinical worsening.¹ ² ³ ⁴ ⁹

Ambrisentan has been used in a limited number of PAH patients in whom therapy with other endothelin-receptor antagonists was discontinued due to aminotransferase elevations.¹ ¹⁴ ¹⁷ In an uncontrolled, open-label study, no patient who previously had aminotransferase elevations (ALT and/or AST >3 × ULN) on bosentan or another investigational endothelin-receptor antagonist (sitaxsentan) required discontinuance of ambrisentan due to aminotransferase elevations (>3 × ULN) during limited long-term follow-up (median of 13 months), and escalation of ambrisentan dosage up to 10 mg daily in 50% of patients.¹ ³ ¹⁴ ¹⁷

Manufacturer suggests that ambrisentan therapy may be tried in patients who have experienced asymptomatic aminotransferase elevations while receiving other endothelin-receptor antagonists, after aminotransferase levels in such patients have normalized.¹

Additional studies needed to clarify the role of selective ET-1 receptor antagonists versus dual ET-1 type A/type B receptor antagonists (e.g., bosentan) in patients with PAH,¹⁴ ¹⁵ and to establish the efficacy of ambrisentan used in conjunction with other PAH therapies (e.g., prostanoids [epoprostenol, iloprost, treprostinil], phosphodiesterase type 5 inhibitors [e.g., sildenafil]).¹⁰ ¹⁴

Ambrisentan Dosage and Administration

General

A risk management plan (Risk Evaluation and Mitigation Strategy, REMS) has been developed for ambrisentan to minimize adverse effects and ensure that benefits outweigh risks of therapy.¹⁸ Ambrisentan can only be obtained through a restricted distribution program because of potential hepatotoxicity and fetotoxicity (see Boxed Warning); available only through physicians and specialty pharmacies registered with the Letairis Education and Access Program (LEAP).¹ ³ ¹³ ¹⁸

Patients must enroll in and meet all conditions of LEAP to obtain ambrisentan, and reenroll after 12 months of treatment and annually thereafter.¹ ¹⁸ Contact LEAP at 866-664-LEAP (5327) for specific information.¹

FDA-approved medication guide must be distributed with each 30-day supply of ambrisentan dispensed and reviewed with every patient.¹ ³ ¹⁶ ¹⁸

Administration

Oral Administration

Administer orally once daily without regard to meals.¹

Do not split, chew, or crush tablets.¹ ³

Dosage

Adults

Pulmonary Arterial Hypertension

Oral

Initially, 5 mg once daily; may increase to maximum of 10 mg once daily if tolerated.¹

Prescribing Limits

Adults

Pulmonary Arterial Hypertension

Oral

Safety and efficacy of dosages >10 mg daily not established.¹

Special Populations

Patients with Adverse Hepatic Effects

If AST or ALT concentrations >8 × ULN, discontinue ambrisentan and do not reinitiate therapy with the drug.¹ ³ In addition, discontinue ambrisentan if AST or ALT concentrations >3 × ULN and are accompanied by manifestations of hepatic disease (e.g., nausea, vomiting, fever, abdominal pain, jaundice, lethargy, fatigue) or bilirubin concentrations >2 × ULN; there is no experience with reinitiation of ambrisentan therapy in these circumstances.¹ ³

If confirmed (i.e., upon a repeat test) AST or ALT elevations >3 but ≤5 × ULN, reduce dosage or interrupt therapy and continue to monitor AST/ALT concentrations at least every 2 weeks until levels are <3 × ULN.¹ ³

If AST or ALT concentrations >5 but ≤8 × ULN, discontinue therapy and continue to monitor AST/ALT concentrations at least every 2 weeks until levels are <3 × ULN.¹ ³

May consider reinitiation of ambrisentan therapy following return of AST/ALT concentrations to pretreatment levels if AST/ALT elevations did not exceed 8 × ULN; monitor aminotransferase concentrations more frequently after reinitiation.¹

Manufacturer states that reinitiation of ambrisentan therapy should not be considered if AST/ALT concentrations exceed 8 × ULN.¹ Clinical experience with reinitiation of therapy is lacking in such patients, as well as in those with AST/ALT elevations accompanied by manifestations of hepatic injury or increases in bilirubin concentrations of >2 × ULN.¹

Hepatic Impairment

Consider reduced dosage in patients with preexisting mild hepatic impairment.¹

Avoid use in patients with preexisting moderate or severe hepatic impairment or with AST/ALT concentrations >3 x ULN.¹ (See Boxed Warning.)

Renal Impairment

Mild or moderate renal impairment: Dosage adjustment not required.¹

Severe renal impairment: Not studied.¹

Patients on hemodialysis: Not studied.¹ ³

Cautions for Ambrisentan

Contraindications

Known, anticipated, or suspected pregnancy.¹ ³

Warnings/Precautions

Hepatic Effects

Risk of elevated serum aminotransferases (AST or ALT) and/or bilirubin concentrations.¹ (See Boxed Warning.) AST/ALT concentrations exceeding 3 × ULN observed in 0.8% of patients after 12 weeks of ambrisentan therapy and 2.8% of patients treated with ambrisentan for 1 year in clinical trials.¹ ³

In at least one patient, concomitant bilirubin elevations exceeding 2 × ULN also reported.¹

Hepatotoxicity appears to be a class effect of endothelin-receptor antagonists.¹ ³ ⁶ ¹⁰ ¹¹ ¹⁴ Rare cases of hepatic cirrhosis and liver failure reported with other drug in this class (e.g., bosentan).⁶ In at least one patient receiving bosentan, marked elevations in liver function test results accompanied by nonspecific symptoms developed after >20 months of therapy, with gradual resolution following drug discontinuance.¹ ⁶

Use in patients with preexisting moderate or severe hepatic impairment not recommended; (see Boxed Warning) use caution in patients with mild hepatic impairment.¹ ³

Perform liver function tests (e.g., AST, ALT, bilirubin) prior to initiation and monthly during therapy.¹ ¹³

Manufacturer recommends strict adherence to monthly monitoring schedule and dosage adjustment guidelines.¹ ¹³ (See Patients with Adverse Hepatic Effects under Dosage and Administration.)

Fetal/Neonatal Morbidity and Mortality

May cause fetal harm; teratogenicity demonstrated in animals and appears to be a class effect of endothelin-receptor antagonists.¹ ⁶

Contraindicated in women who are or may become pregnant.¹ ¹⁸ (See Boxed Warning.)

Exclude pregnancy prior to initiation of therapy and perform monthly pregnancy tests during therapy.¹

Must use 2 acceptable methods of contraception during and for 1 month following cessation of therapy; alternatively, if patient has had a Copper T380A or LNg 20 IUD inserted or has undergone tubal sterilization, no other contraceptive method is required.¹ ³ ¹⁶ ¹⁸ (See Advice to Patients.)

Fertility in Males

Reduced sperm counts observed in some men following treatment with another endothelin receptor antagonist (bosentan); possibility of adverse effects on spermatogenesis with ambrisentan cannot be excluded.¹

Hematologic Effects

Mild decreases in hemoglobin and hematocrit reported during the first few weeks of treatment, followed by stabilization; hemoglobin decreases do not appear to be related to hemorrhage or hemolysis.¹ ³ ⁴ ⁹

Monitor hemoglobin concentrations and hematocrit prior to initiation, at 1 month, and periodically during therapy.¹ ³ ¹³

Discontinue ambrisentan if clinically important, otherwise unexplained reductions in hemoglobin observed.¹ ³

Fluid Retention

Peripheral edema reported, usually mild to moderate in severity; occurred with greater frequency and severity in geriatric patients.¹ Peripheral edema is a known class effect of endothelin-receptor antagonists and also a consequence of PAH.¹ Fluid retention, sometimes requiring intervention (e.g., diuretics, fluid management, hospitalization), reported during postmarketing surveillance.¹

Monitor patients for clinically important fluid retention and initiate appropriate treatment or discontinue ambrisentan if necessary.¹

Specific Populations

Pregnancy

Category X.¹ (See Fetal/Neonatal Morbidity and Mortality and also Contraindications, under Cautions.)

Lactation

Decreased survival in newborn rats following maternal exposure to ambrisentan.¹ Not known whether ambrisentan is distributed into human milk.¹ Use not recommended during breast-feeding.¹

Pediatric Use

Safety and efficacy not established in children and adolescents <18 years of age.¹ ³

Geriatric Use

Higher incidence of peripheral edema observed in patients ≥65 years of age relative to younger adults.¹

Hepatic Impairment

Substantially metabolized and eliminated by the liver and biliary system.¹ Avoid use in patients with moderate to severe hepatic impairment or with AST/ALT concentrations >3 × ULN.¹ Use with caution in patients with mild hepatic impairment and consider reduced dosage.¹

Renal Impairment

Safety and efficacy not established in patients with severe renal impairment.¹

No clinically important impact of mild or moderate renal impairment on ambrisentan disposition.¹ (See Renal Impairment under Dosage and Administration.)

Common Adverse Effects

Peripheral edema,¹ nasal congestion,¹ sinusitis,¹ flushing,¹ palpitations,¹ nasopharyngitis,¹ abdominal pain,¹ constipation,¹ dyspnea,¹ headache.¹ ³

Interactions for Ambrisentan

Interaction potential of ambrisentan not well characterized; lack of in vivo interaction studies with strong inhibitors/inducers of CYP 3A4 or 2C19, strong inhibitors of p-glycoprotein or organic anion transport protein (OATP), or with inducers of CYPs, uridine diphosphate glucuronosyltransferase (UGT) or p-glycoprotein.¹ ³

In vitro evidence suggests metabolism by UGT enzymes 1A9, 2B7, and 1A3 and by CYP3A4 and CYP2C19.¹ ³ ¹⁴

Substrate of p-glycoprotein and OATP.¹ ³

Ambrisentan does not inhibit p-glycoprotein,¹ ³

Drugs Affecting Hepatic Microsomal Enzymes

Strong inhibitors of CYP3A4 or CYP2C19: Potential pharmacokinetic interactions (increased plasma concentrations of ambrisentan).¹ ³

Drugs Affecting the p-Glycoprotein Transport System

Pharmacokinetic interactions possible with strong inhibitors or inducers of p-glycoprotein.¹

Drugs Affecting Uridine Diphosphate Glucuronosyltransferase Enzymes

Pharmacokinetic interactions possible with drugs that induce UGT 1A9, 2B7, or 1A3.¹ Use concomitantly with caution.¹

Specific Drugs

Drug	Interaction	Comments
Antibiotics, macrolide (e.g., clarithromycin, telithromycin)	Possible increased ambrisentan concentrations; in vivo studies with specific drugs lacking¹ ³	Use with caution¹
Antifungals, azole (e.g., itraconazole, ketoconazole)	Possible increased ambrisentan concentrations; in vivo studies with specific drugs lacking¹ ³	Use with caution¹
Antiretrovirals (e.g., atazanavir, indinavir, nelfinavir, ritonavir, saquinavir)	Possible increased ambrisentan concentrations; in vivo studies with specific drugs lacking¹ ³	Use with caution¹
Cyclosporine	Possible increased ambrisentan concentrations; in vivo studies with specific drugs lacking¹ ³	Use with caution¹
Nefazodone	Possible increased ambrisentan concentrations; in vivo studies with specific drugs lacking¹ ³	Use with caution¹
Omeprazole	Possible increased ambrisentan concentrations; in vivo studies with specific drugs lacking¹ ³	Use with caution¹
Rifampin	Possible pharmacokinetic interaction through induction of p-glycoprotein and hepatic microsomal enzymes (CYP3A4 and CYP2C19) and inhibition of OATP transport systems; in vivo studies with specific drugs lacking¹ ³	Use with caution¹
Sildenafil	Clinically important interaction not observed¹ ¹⁴	No dosage adjustment of ambrisentan or sildenafil required¹
Warfarin	Clinically important interaction not observed¹ ² ⁴ ⁹ ¹⁴	No dosage adjustment of ambrisentan or warfarin required¹

Ambrisentan Pharmacokinetics

Absorption

Bioavailability

Rapidly absorbed following oral administration,¹ ³ ⁹ with peak plasma concentrations attained within approximately 2 hours after oral administration.¹ ⁹ ¹² Absolute bioavailability unknown.¹ ³ ¹⁴

Food

Food does not affect absorption.¹ ³

Distribution

Extent

Detected in liver and plasma 2–4 hours after administration.³ ¹⁴

Plasma Protein Binding

99%.¹

Elimination

Metabolism

Undergoes hepatic metabolism, principally by glucuronidation and to a lesser extent by hydroxylation.¹ ¹⁴

Elimination Route

Predominantly non renal pathways; contributions of metabolism and biliary excretion not well characterized.¹ ³ Most of radiolabeled dose recovered in feces as unchanged drug or glucuronide metabolite.¹ ¹² ¹⁴

Half-life

Terminal half-life 15 hours; effective half-life approximately 9 hours.¹ ³ ⁹

Special Populations

Potential for increased exposure to ambrisentan in patients with hepatic impairment.¹ (See Hepatic Impairment under Cautions.)

Serum ambrisentan concentrations not affected in patients with mild or moderate renal impairment (based on studies in individuals with Cl_cr 20–150 mL/minute).¹

Stability

Storage

Oral

Tablets

25°C (may be exposed to 15–30°C) in original package.¹

Actions

Exhibits specific, selective antagonism of ET-1 type A receptor in the endothelium and vascular smooth muscle.¹ ³ ¹⁴ Increased concentrations of ET-1, a potent vasoconstrictor, have been detected in the plasma and lung tissue of patients with PAH, suggesting a pathogenic role for ET-1 in this disorder.⁵ ⁷

Pharmacologically related to other ET-1 receptor antagonists (e.g., bosentan), but exhibits 4000-fold greater selectivity for ET-1 type A receptor versus type B receptor.¹ ³ ⁶ ¹⁷ Clinical implications of receptor selectivity currently not established.¹ ¹⁴ ¹⁵

Improves exercise capacity in PAH patients by inhibiting ET-1 type A receptor-mediated vasoconstriction and cell proliferation.¹ ² ⁴ ⁹

Advice to Patients

Importance of taking medication as prescribed and of not interrupting or discontinuing therapy without consulting a clinician.¹⁶

Importance of not taking a double dose to make up for a missed dose but instead taking the next scheduled dose.¹⁶

Risk of liver injury.¹ ¹⁶ Importance of patient promptly informing clinician of any nausea, vomiting, appetite loss, fever, unusual tiredness, abdominal pain, dark urine, itching, or yellowing of the skin or white of the eyes.¹ ¹⁶

Importance of women informing their clinician if they are or plan to become pregnant or plan to breast-feed.¹ ¹⁶

Importance of avoiding pregnancy and using 2 highly reliable forms of contraception (either one hormonal and one barrier method or 2 barrier methods, one of which is the male condom) simultaneously during and for 1 month following therapy.¹ ¹⁶ ¹⁸ Acceptable hormonal methods include progesterone injections, progesterone implants, estrogen-progestin combination oral contraceptives, transdermal contraceptive systems, and vaginal ring.¹ Acceptable barrier methods include diaphragms with spermicide, cervical caps with spermicide, and male condoms.¹ No additional contraception is necessary if patient has undergone tubal sterilization or chooses to use a Copper T380A or LNg 20 IUD.¹ If the partner has had a vasectomy, an additional hormonal or barrier method must be used.¹ ¹⁸ Advise women to inform their clinician immediately if a menstrual period is missed or pregnancy suspected.¹ ¹⁶ Apprise patient of potential risk to fetus if pregnancy occurs.¹ ¹⁶

Importance of monthly monitoring of liver function tests and monthly pregnancy testing.¹ ¹⁶

Importance of periodic monitoring of red blood cell counts during treatment.¹ ¹⁶

Importance of advising patients to swallow tablets whole and not to split, chew, or crush tablets.¹ ¹⁶

Importance of distributing FDA-approved medication guide to every patient who receives ambrisentan and reviewing the information with the patient.¹ ¹⁸

Importance of patients carefully reading medication guide before initiating therapy, and each time prescription is refilled.¹ ¹⁶

Importance of informing clinicians of existing or contemplated concomitant therapy including prescription and OTC drugs, as well as concomitant illnesses.¹ ¹⁶

Importance of informing patients of other important precautionary information.¹ ¹⁶ (See Cautions.)

Preparations

Excipients in commercially available drug preparations may have clinically important effects in some individuals; consult specific product labeling for details.

Distribution of ambrisentan is restricted.¹ (See General under Dosage and Administration.)

Ambrisentan
Routes	Dosage Forms	Strengths	Brand Names	Manufacturer
Oral	Tablets, film-coated	5 mg	Letairis	Gilead
		10 mg	Letairis	Gilead

Disclaimer

This report on medications is for your information only, and is not considered individual patient advice. Because of the changing nature of drug information, please consult your physician or pharmacist about specific clinical use.

The American Society of Health-System Pharmacists, Inc. and Drugs.com represent that the information provided hereunder was formulated with a reasonable standard of care, and in conformity with professional standards in the field. The American Society of Health-System Pharmacists, Inc. and Drugs.com make no representations or warranties, express or implied, including, but not limited to, any implied warranty of merchantability and/or fitness for a particular purpose, with respect to such information and specifically disclaims all such warranties. Users are advised that decisions regarding drug therapy are complex medical decisions requiring the independent, informed decision of an appropriate health care professional, and the information is provided for informational purposes only. The entire monograph for a drug should be reviewed for a thorough understanding of the drug's actions, uses and side effects. The American Society of Health-System Pharmacists, Inc. and Drugs.com do not endorse or recommend the use of any drug. The information is not a substitute for medical care.

AHFS Drug Information. © Copyright, 1959-2011, Selected Revisions October 27, 2011. American Society of Health-System Pharmacists, Inc., 7272 Wisconsin Avenue, Bethesda, Maryland 20814.

References

1. Gilead Sciences, Inc. Letairis (ambrisentan) tablets prescribing information. Foster City, CA; 2009 July.

2. Oudiz RJ, Torres F, Frost AE et al. A placebo-controlled, efficacy and safety study of ambrisentan in patients with pulmonary arterial hypertension (ARIES-1). Chest. 2006; 130(4 suppl):121S.

3. Gilead Sciences: Personal communication.

4. Oudiz RJ, Olschewski H, Galie N et al. Ambrisentan improves exercise capacity and time to clinical worsening in patients with pulmonary arterial hypertension: results of the ARIES-2 study. Poster presented at the 7^th International Pulmonary Hypertension Association (PHA) Conference. Minneapolis, MN: 2006 June 23-25.

5. Giaid A, Yanagisawa M, Langleben D et al. Expression of endothelin-1 in the lungs of patients with pulmonary hypertension. N Engl J Med. 1993; 328:1732-39. [PubMed 8497283]

6. Actelion Pharmaceuticals US. Tracleer (bosentan) tablets prescribing information. South San Francisco, CA: 2007 Feb 15

7. Stewart DJ, Levy RD, Cernacek P et al. Increased plasma endothelin-1 in pulmonary hypertension: Marker or mediator of disease. Ann Intern Med. 1991; 114:464-9. [PubMed 1994793]

8. Benigni A, Remuzzi G. Endothelin antagonists. Lancet. 1999; 353:133-38. [PubMed 10023915]

9. Galie N, Badesch D, Oudiz R et al. Ambrisentan therapy for pulmonary arterial hypertension. J Am Coll Cardiol. 2005; 46:529-35. [PubMed 16053970]

10. Channick RN, Sitbon O, Barst RJ et al. Endothelin receptor antagonists in pulmonary arterial hypertension. J Am Coll Cardiol. 2004; 43 (Suppl S):62-7.

11. Barst RJ, Langleben D, Badesch D et al. Treatment of pulmonary arterial hypertension with the selective endothelin-A receptor antagonist sitaxsentan. J Am Coll Cardiol. 2006; 47:2049-56. [PubMed 16697324]

12. Vatter H, Seifert V. Ambrisentan, a non-peptide endothelin receptor antagonist. Cardiovasc Drug Rev. 2006; 24:63-76. [PubMed 16939634]

13. Gilead Sciences. Letairis education and access program (LEAP) prescriber information. Foster City, CA; 2007 Jun.

14. Barst RJ. A review of pulmonary arterial hypertension: role of ambrisentan. Vasc Health Risk Manag. 2007; 3:11-22. [PubMed 17583171]

15. Jacobs A, Preston IR, Gomberg-Maitland M. Endothelin receptor antagonism in pulmonary arterial hypertension-a role for selective ET_Ainhibition? Curr Med Res Opin. 2006; 22:2567-74.

16. Gilead Sciences, Inc. Letairis (ambrisentan) tablets medication guide. Foster City, CA; 2007 Jun.

17. McGoon M, Frost A, Rubin L et al. Ambrisentan therapy in patients with pulmonary arterial hypertension who discontinued bosentan or sitaxsentan due to liver function abnormalities: 1 year follow-up. Presented at the 103^nd American Thoracic Society annual international conference. San Francisco, CA: 2007 May 18-23.

18. Food and Drug Administration. Medwatch-Safety-Related drug labeling changes: Letairis (ambrisentan) 5 and 10 mg tablets [May 2009]. From FDA website http://www.fda.gov/Safety/MedWatch/SafetyInformation/ucm165575.htm.

More Ambrisentan resources

Ambrisentan Side Effects (in more detail)
Ambrisentan Dosage
Ambrisentan Use in Pregnancy & Breastfeeding
Ambrisentan Drug Interactions
Ambrisentan Support Group
2 Reviews for Ambrisentan - Add your own review/rating

Ambrisentan MedFacts Consumer Leaflet (Wolters Kluwer)

Ambrisentan Professional Patient Advice (Wolters Kluwer)

ambrisentan Advanced Consumer (Micromedex) - Includes Dosage Information

Letairis Prescribing Information (FDA)

Letairis Consumer Overview

Compare Ambrisentan with other medications

Pulmonary Arterial Hypertension

Obagi Skin Lightening Complex

Dosage Form: lotion
Obagi® Skin Lightening Complex

(Hydroquinone USP, 4%)

Skin Bleaching Cream

Rx Only

FOR EXTERNAL USE ONLY

INGREDIENTS

Each gram of Skin Lightening Complex contains Hydroquinone USP 40 mg/g in a base of Ascorbic Acid, BHT, Cetyl Alcohol, Disodium EDTA, Glycerin, Lactic Acid, Methylparaben, Phenyl Trimethicone, PPG-2 Myristyl Ether Propionate, Propylparaben, Saponins, Sodium Lauryl Sulfate, Sodium Metabisulfite, TEA-Salicylate, Tocopheryl Acetate and Water.

Obagi Skin Lightening Complex Description

Hydroquinone is 1,4-benzenediol. The drug is freely soluble in water and in alcohol. Chemically, hydroquinone is designated as p-dihydroxybenzene; the empirical formula is C6H6O2; the molecular weight is 110.11 g/mol. The chemical structure is the diagram to the right.

Obagi Skin Lightening Complex - Clinical Pharmacology

Topical application of hydroquinone produces a reversible depigmentation of the skin by inhibition of the enzymatic oxidation of tyrosine to 3, 4-dihydroxyphenylalanine (dopa) and suppression of other melanocyte metabolic processes.

Exposure to sunlight or ultraviolet light will cause repigmentation of the bleached areas, which may be prevented by the use of sunblocking agents or sunscreen agents.

Indications and Usage for Obagi Skin Lightening Complex

For the gradual bleaching of hyperpigmented skin conditions such as chloasma, melasma, freckles, senile lentigines, and other unwanted areas of melanin hyperpigmentation.

Contraindications

People with prior history of sensitivity or allergic reaction to this product or any of its ingredients should not use it. The safety of topical hydroquinone use during pregnancy or in children (12 years and under) has not been established.

Obagi Skin Lightening Complex Dosage and Administration

A thin application should be applied to the chest and neck area twice daily or as directed by a physician. If no improvement is seen after 8-12 weeks of treatment, use of this product should be discontinued. Sun exposure should be limited by using a sunscreen agent, a sunblocking agent, or protective clothing to cover bleached skin when using and after using this product in order to prevent repigmentation.

Warnings

Hydroquinone is a skin bleaching agent, which may produce unwanted cosmetic effects if not used as directed. The physician should be familiar with the contents of this insert before prescribing or dispensing this medication.

Test for skin sensitivity before using by applying a small amount to an unbroken patch of skin and check within 24 hours. Minor redness is not a contraindication, but where there is itching or vesicle formation or excessive inflammatory response, the product should be discontinued and a physician consulted. Close patient supervision is recommended.

Avoid contact with the eyes, nose, mouth, or lips. In case of accidental contact, the patient should rinse the eyes, nose, mouth, or lips with water and contact a physician.

Sunscreen use is an essential aspect of hydroquinone therapy because even minimal sunlight exposure sustains melanocytic activity.

Contains sodium metabisulfite, a sulfite that may cause allergic-type reactions including anaphylactic symptoms and life-threatening or less severe asthmatic episodes in certain susceptible people. The overall prevalence of sulfite sensitivity in the general population is unknown and probably low. Sulfite sensitivity is seen more frequently in asthmatic than in nonasthmatic people.

Precautions

(ALSO SEE WARNINGS)

Treatment should be limited to relatively small areas of the body at one time since some patients experience a transient skin reddening and a mild burning sensation, which does not preclude treatment.

PREGNANCY CATEGORY C

Animal reproduction studies have not been conducted with topical hydroquinone. It is also not known whether hydroquinone can cause fetal harm when used topically on a pregnant woman or affect reproductive capacity. It is not known to what degree, if any, topical hydroquinone is absorbed systemically. Topical hydroquinone should be used on pregnant women only when clearly indicated.

NURSING MOTHERS

It is not known whether topical hydroquinone is absorbed or excreted in human milk. Caution is advised when topical hydroquinone is used by a nursing mother.

PEDIATRIC USAGE

Safety and effectiveness in children below the age of 12 years have not been established.

Adverse Reactions

No systemic adverse reactions have been reported. Occasional hypersensitivity (localized contact dermatitis) may occur, in which case the product should be discontinued and the physician notified immediately.

How is Obagi Skin Lightening Complex Supplied

Obagi Skin Lightening Complex is available as follows:

2.0 oz (57 g) tube

NDC 63032-120-60

Store at controlled room temperature:

15°-25°C (59°F-77°F)

OBAGI®

MEDICAL

Obagi is a registered trademark of OMP, Inc.

Distributed by OMP, Inc.

Obagi Medical Products, Inc.

Long Beach, CA 90806

USA

www.obagi.com

60650611X

PRINCIPAL DISPLAY PANEL - 57 g Carton

NDC 62032-120-60

OBAGI®

MEDICAL

ELASTIderm®

décolletage

Chest and Neck

Skin

Lightening

Complex

Hydroquinone USP, 4%

Rx Only

NET WT 2.0 OZ. (57 g)

ELASTIDERM DECOLLETAGE SKIN LIGHTENING COMPLEX CHEST AND NECK
hydroquinone lotion

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	NDC Product Code (Source)	62032-120
Route of Administration	TOPICAL	DEA Schedule

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
HYDROQUINONE (HYDROQUINONE)	HYDROQUINONE	40 mg in 1 g

Inactive Ingredients
Ingredient Name	Strength
EDETATE DISODIUM
TROLAMINE SALICYLATE
SODIUM LAURYL SULFATE
CETYL ALCOHOL
GLYCERIN
LACTIC ACID
ALPHA-TOCOPHEROL ACETATE
ASCORBIC ACID
SODIUM METABISULFITE
WATER
METHYLPARABEN
PROPYLPARABEN
BUTYLATED HYDROXYTOLUENE
PHENYL TRIMETHICONE

Product Characteristics
Color	GRAY	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	NDC	Package Description	Multilevel Packaging
1	62032-120-60	1 TUBE In 1 CARTON	contains a TUBE
1		57 g In 1 TUBE	This package is contained within the CARTON (62032-120-60)

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
UNAPPROVED DRUG OTHER		12/01/2010

Labeler - OMP, INC. (790553353)

Establishment
Name	Address	ID/FEI	Operations
PURETEK CORPORATION		785961046	MANUFACTURE, LABEL, PACK

Revised: 12/2011OMP, INC.

Monday, October 24, 2016

Dulera

Generic Name: mometasone and formoterol (Inhalation route)

for-MOE-ter-ol FUE-ma-rate, moe-MET-a-sone FURE-oh-ate

Commonly used brand name(s)

In the U.S.

Dulera

Available Dosage Forms:

Aerosol Powder

Therapeutic Class: Antiasthma, Anti-Inflammatory/Bronchodilator Combination

Pharmacologic Class: Formoterol

Uses For Dulera

Mometasone and formoterol is a combination of two medicines that are used to help control the symptoms of asthma and improve lung function. It is used when a patient's asthma has not been controlled sufficiently on other asthma medicines, or when a patient's condition is so severe that more than one medicine is needed every day. This medicine will not relieve an asthma attack that has already started.

Inhaled mometasone belongs to the family of medicines known as corticosteroids (cortisone-like medicines). It works by preventing inflammation (swelling) in the lungs that causes an asthma attack.

Inhaled formoterol belongs to the family of medicines known as bronchodilators. It works by helping the muscles around the airways in your lungs stay relaxed to prevent asthma symptoms, such as wheezing and shortness of breath.

This medicine is available only with your doctor's prescription.

Before Using Dulera

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Appropriate studies performed to date have not demonstrated pediatric-specific problems that would limit the usefulness of mometasone and formoterol combination in children. However, safety and efficacy have not been established in children younger than 12 years of age.

Geriatric

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of mometasone and formoterol combination in the elderly. However, elderly patients with heart problems may require special caution when receiving mometasone and formoterol combination.

Pregnancy

	Pregnancy Category	Explanation
All Trimesters	C	Animal studies have shown an adverse effect and there are no adequate studies in pregnant women OR no animal studies have been conducted and there are no adequate studies in pregnant women.

Breast Feeding

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Interactions with Medicines

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

Acebutolol

Alprenolol

Arotinolol

Atenolol

Befunolol

Betaxolol

Bevantolol

Bisoprolol

Bopindolol

Brofaromine

Bucindolol

Bupranolol

Carteolol

Carvedilol

Celiprolol

Clorgyline

Dilevalol

Esmolol

Furazolidone

Iproniazid

Isocarboxazid

Labetalol

Landiolol

Lazabemide

Levobetaxolol

Levobunolol

Linezolid

Mepindolol

Metipranolol

Metoprolol

Moclobemide

Nadolol

Nebivolol

Nialamide

Nipradilol

Oxprenolol

Pargyline

Penbutolol

Phenelzine

Pindolol

Procarbazine

Propranolol

Rasagiline

Selegiline

Sotalol

Talinolol

Tertatolol

Timolol

Toloxatone

Tranylcypromine

Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

Ketoconazole

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Proper Use of Dulera

This medicine is used with a special inhaler and usually comes with patient directions or a Medication Guide. Read the directions carefully before using this medicine. If you do not understand the directions or you are not sure how to use the inhaler, ask your doctor or pharmacist to show you what to do.

Use this medicine only as directed. Do not use more of it and do not use it more often than your doctor ordered. Also, do not stop taking this medicine without telling your doctor. To do so may increase the chance of side effects.

When you use the inhaler for the first time, or if you have not used it for 5 days or longer, it may not deliver the right amount of medicine with the first puff. Therefore, before using the inhaler, prime it by spraying the medicine four times into the air away from the face, and shaking it well before each spray.

How to use this medicine:

Take the inhaler out of the carton before you use it for the first time.

Do not use the inhaler for this medicine with any other medicine.

Remove the cap and look at the mouthpiece to make sure it is clean.

Prime the inhaler before use by shaking the inhaler well and then releasing 4 test sprays.

To inhale this medicine, breathe out fully, trying to get as much air out of the lungs as possible. Put the mouthpiece fully into your mouth and close your lips around it. Do not block the mouthpiece with your teeth or tongue.

While pressing down firmly and fully on the blue top of the inhaler, breathe in through your mouth as deeply as you can until you have taken a full deep breath.

Repeat these steps for the next puff, starting with shaking the inhaler.

Replace the mouthpiece cover after using the medicine.

Gargle and rinse your mouth with water after each dose; this will help prevent hoarseness, throat irritation, and infection in the mouth. Do not swallow the water after rinsing.

Dosing

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

For inhalation dosage form (aerosol):
- For preventing an asthma attack:
  - Adults and children 12 years of age and older—Two puffs in the morning and another 2 puffs in the evening. Each puff contains 100 or 200 micrograms (mcg) of mometasone and 5 mcg of formoterol.
  - Children younger than 12 years of age—Use and dose must be determined by your child's doctor.

Missed Dose

If you miss a dose of this medicine, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Store the canister at room temperature, away from heat and direct light. Do not freeze. Do not keep this medicine inside a car where it could be exposed to extreme heat or cold. Do not poke holes in the canister or throw it into a fire, even if the canister is empty.

When you store the inhaler, make sure to always place the mouthpiece down.

Precautions While Using Dulera

It is very important that your doctor check the progress of you or your child at regular visits, to make sure that this medicine is working properly and to check for any unwanted effects that may be caused by this medicine. You may need to have your eyes checked at regular visits. Be sure to keep all appointments.

Although this medicine decreases the number of asthma episodes, it may increase the chances of a severe asthma episode when they do occur. Talk to your doctor or pharmacist about any questions or concerns that you have.

You or your child should not use this medicine if your asthma attack has already started or if you already have a severe asthma attack. Your doctor may prescribe another medicine (e.g., a short-acting inhaler) for you to use in case of an acute asthma attack. Call your doctor immediately for instructions.

Do not use any other asthma medicine or medicine for breathing problems without talking to your doctor. This medicine should not be used with arformoterol (Brovana®), budesonide/formoterol (Symbicort®), formoterol (Foradil®, Perforomist™), or salmeterol (Serevent®) inhalers.

Talk to your doctor or get medical care right away if:

Your or your child's symptoms do not improve after using this medicine for 1 week or if they become worse.

Your short-acting inhaler does not seem to be working as well as usual and you need to use it more often (e.g.; you use 1 whole canister of your short-acting inhaler in 8 weeks time, or you need to use 4 or more inhalations of your short-acting inhaler for 2 or more days in a row).

You or your child have a significant decrease in your peak flow when measured as directed by your doctor.

Your doctor may want you to carry a medical identification card stating that you or your child are using this medicine and that you may need additional medicine during times of emergency, a severe asthma attack or other illness, or unusual stress.

You may get infections more easily while using this medicine. Tell your doctor right away if you or your child have been exposed to someone with chickenpox or measles.

This medicine may cause fungus infection of the mouth or throat (thrush). Tell your doctor right away if you have white patches in the mouth or throat; or pain when eating or swallowing.

Using too much of this medicine or using it for a long time may increase your risk of having adrenal gland problems. Talk to your doctor if you or your child have more than one of these symptoms while you are using this medicine: darkening of the skin; diarrhea; dizziness; fainting; loss of appetite; mental depression; nausea; skin rash; unusual tiredness or weakness; or vomiting.

If you or your child develop a skin rash, hives, or any allergic reaction to this medicine, stop using the medicine and check with your doctor as soon as possible.

This medicine may decrease bone mineral density when used for a long time. A low bone mineral density can cause weak bones or osteoporosis. If you have any questions about this, ask your doctor.

This medicine may cause children to grow more slowly than usual. Talk to your child's doctor if you have any concerns.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

Dulera Side Effects

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

Less common

Cough

fever

headache

muscle aches

pain or tenderness around the eyes and cheekbones

shortness of breath or troubled breathing

sore throat

stuffy or runny nose

tightness of the chest or wheezing

unusual tiredness or weakness

Rare

Sore mouth or tongue

white patches in the mouth or on the tongue

Incidence not known

Blindness

blurred vision

cough or hoarseness

creamy white, curd-like patches in the mouth or throat

darkening of the skin

decreased vision

diarrhea

dizziness

eye pain

fainting

fever or chills

loss of appetite

lower back or side pain

mental depression

nausea or vomiting

pain when eating or swallowing

painful or difficult urination

skin rash

tearing

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

Less common

Voice changes

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

See also: Dulera side effects (in more detail)

The information contained in the Thomson Reuters Micromedex products as delivered by Drugs.com is intended as an educational aid only. It is not intended as medical advice for individual conditions or treatment. It is not a substitute for a medical exam, nor does it replace the need for services provided by medical professionals. Talk to your doctor, nurse or pharmacist before taking any prescription or over the counter drugs (including any herbal medicines or supplements) or following any treatment or regimen. Only your doctor, nurse, or pharmacist can provide you with advice on what is safe and effective for you.

The use of the Thomson Reuters Healthcare products is at your sole risk. These products are provided "AS IS" and "as available" for use, without warranties of any kind, either express or implied. Thomson Reuters Healthcare and Drugs.com make no representation or warranty as to the accuracy, reliability, timeliness, usefulness or completeness of any of the information contained in the products. Additionally, THOMSON REUTERS HEALTHCARE MAKES NO REPRESENTATION OR WARRANTIES AS TO THE OPINIONS OR OTHER SERVICE OR DATA YOU MAY ACCESS, DOWNLOAD OR USE AS A RESULT OF USE OF THE THOMSON REUTERS HEALTHCARE PRODUCTS. ALL IMPLIED WARRANTIES OF MERCHANTABILITY AND FITNESS FOR A PARTICULAR PURPOSE OR USE ARE HEREBY EXCLUDED. Thomson Reuters Healthcare does not assume any responsibility or risk for your use of the Thomson Reuters Healthcare products.

More Dulera resources

Dulera Side Effects (in more detail)
Dulera Use in Pregnancy & Breastfeeding
Dulera Drug Interactions
Dulera Support Group
6 Reviews for Dulera - Add your own review/rating

Dulera Prescribing Information (FDA)

Dulera Inhalation Aerosol MedFacts Consumer Leaflet (Wolters Kluwer)

Dulera Consumer Overview

Compare Dulera with other medications

Asthma
Asthma, Maintenance

Proventil Inhalation

Generic Name: albuterol (Inhalation route)

al-BUE-ter-ol

Commonly used brand name(s)

In the U.S.

Accuneb

ProAir HFA

Proventil

Proventil HFA

ReliOn Ventolin HFA

Ventolin

Ventolin HFA

In Canada

Alti-Salbutamol Inhalation Aerosol

Apo-Salvent

Salbutamol

Salbutamol Nebuamp

Salbutamol Respirator Solution

Ventolin Inhaler

Ventolin Nebules P.F.

Ventolin Respirator

Ventolin Rotacaps

Available Dosage Forms:

Aerosol Powder

Solution

Capsule

Powder

Therapeutic Class: Bronchodilator

Pharmacologic Class: Sympathomimetic

Uses For Proventil

Albuterol is used to treat or prevent bronchospasm in patients with asthma, bronchitis, emphysema, and other lung diseases. This medicine is also used to prevent wheezing caused by exercise (exercise-induced bronchospasm).

Albuterol belongs to the family of medicines known as adrenergic bronchodilators. Adrenergic bronchodilators are medicines that are breathed in through the mouth to open up the bronchial tubes (air passages) in the lungs. They relieve cough, wheezing, shortness of breath, and troubled breathing by increasing the flow of air through the bronchial tubes.

This medicine is available only with your doctor's prescription.

Once a medicine has been approved for marketing for a certain use, experience may show that it is also useful for other medical problems. Although these uses are not included in product labeling, albuterol is used in certain patients with the following medical condition:

Hyperkalemia (too much potassium in the blood).

Before Using Proventil

Allergies

Pediatric

Appropriate studies performed to date have not demonstrated pediatric-specific problems that would limit the usefulness of albuterol inhalation aerosol (e.g., Proair® HFA) in children 4 years of age and older and albuterol inhalation solution (e.g., Accuneb®) in children 2 years of age and older. However, safety and efficacy have not been established for the aerosol in children younger than 4 years of age and for the solution in children younger than 2 years of age.

Geriatric

No information is available on the relationship of age to the effects of albuterol inhalation solution (e.g., Accuneb®) in geriatric patients.

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of albuterol inhalation aerosol (e.g., Proair® HFA) in geriatric patients. However, elderly patients are more likely to have age-related heart or kidney problems, which may require caution and an adjustment in the dose for patients receiving albuterol.

Pregnancy

	Pregnancy Category	Explanation
All Trimesters	C	Animal studies have shown an adverse effect and there are no adequate studies in pregnant women OR no animal studies have been conducted and there are no adequate studies in pregnant women.

Breast Feeding

Interactions with Medicines

Acebutolol

Alprenolol

Arotinolol

Atenolol

Atomoxetine

Befunolol

Betaxolol

Bevantolol

Bisoprolol

Bopindolol

Brofaromine

Bucindolol

Bupranolol

Carteolol

Carvedilol

Celiprolol

Clorgyline

Dilevalol

Esmolol

Furazolidone

Iproniazid

Isocarboxazid

Labetalol

Landiolol

Lazabemide

Levobetaxolol

Levobunolol

Linezolid

Mepindolol

Metipranolol

Metoprolol

Moclobemide

Nadolol

Nebivolol

Nialamide

Nipradilol

Oxprenolol

Pargyline

Penbutolol

Phenelzine

Pindolol

Procarbazine

Propranolol

Rasagiline

Selegiline

Sotalol

Talinolol

Tertatolol

Timolol

Toloxatone

Tranylcypromine

Interactions with Food/Tobacco/Alcohol

Proper Use of albuterol

This section provides information on the proper use of a number of products that contain albuterol. It may not be specific to Proventil. Please read with care.

Use this medicine only as directed by your doctor. Do not use more of it and do not use it more often than your doctor ordered. Also, do not stop using this medicine or any asthma medicine without telling your doctor. To do so may increase the chance for breathing problems.

The albuterol inhalation solution (e.g., Accuneb®) should be used with a jet nebulizer that is connected to an air compressor with good air flow. The inhalation solution and nebulizer will come with patient instructions. Read and follow these instructions carefully. Ask your doctor if you have any questions.

To use the inhalation solution in the nebulizer:

Use one container of solution or mix the exact amount of solution using the dropper provided for each dose.

Place the inhalation solution in the medicine reservoir or nebulizer cup on the machine.

Connect the nebulizer to the face mask or mouthpiece.

Use the face mask or mouthpiece to breathe in the medicine.

Use the nebulizer for about 5 to 15 minutes, or until the medicine in the nebulizer cup is gone.

Clean all the parts of the nebulizer after each use.

The albuterol inhalation aerosol (e.g., Proair® HFA) is used with a special inhaler that comes with patient instructions. Read the directions carefully before using this medicine. If you or your child do not understand the directions or are not sure how to use the inhaler, ask your doctor to show you what to do. Also, ask your doctor to check you or your child on a regular basis to make sure you are using it properly.

To use the aerosol inhaler:

The inhaler should be at room temperature before you use it.

Insert the metal canister firmly and fully into the clear end of the Proair® HFA mouthpiece. This mouthpiece should not be used with other inhaled medicines.

Remove the cap and look at the mouthpiece to make sure it is clean.

Shake the inhaler well and test spray it in the air 3 times before using it for the first time or if the inhaler has not been used for more than 2 weeks.

To inhale this medicine, breathe out fully, trying to get as much air out of the lungs as possible. Put the mouthpiece just in front of your mouth with the canister upright.

Open your mouth and breathe in slowly and deeply (like yawning), and at the same time firmly press down once on the top of the canister.

Hold your breath for about 10 seconds, then breathe out slowly.

If you are supposed to use more than one puff, wait 1 minute before inhaling the second puff. Repeat these steps for the second puff, starting with shaking the inhaler.

When you have finished all of your doses, rinse your mouth with water and spit the water out.

Clean the inhaler mouthpiece at least once a week with warm running water for 30 seconds, and dry it completely.

If you need to use the inhaler before it is completely dry, shake off the excess water, replace the canister, and spray it 2 times in the air away from the face. Use your regular dose.

After using the inhaler, wash the mouthpiece again and dry it completely.

If the mouthpiece becomes blocked, washing it will help.

Dosing

For inhalation aerosol dosage form (inhaler):
- For preventing bronchospasm:
  - Adults, teenagers, and children 4 years of age and older—Two puffs every 4 to 6 hours as needed.
  - Children younger than 4 years of age—Use and dose must be determined by your child's doctor.
- For preventing exercise-induced bronchospasm:
  - Adults, teenagers, and children 4 years of age and older—Two puffs taken 15 to 30 minutes before exercise.
  - Children younger than 4 years of age—Use and dose must be determined by your child's doctor.

For inhalation solution dosage form (used with a nebulizer):
- For preventing bronchospasm:
  - Adults and children older than 12 years of age—2.5 milligrams (mg) in the nebulizer 3 or 4 times per day as needed.
  - Children 2 to 12 years of age—0.63 to 1.25 mg in the nebulizer 3 or 4 times per day as needed.
  - Children younger than 2 years of age—Use and dose must be determined by your child's doctor.

Missed Dose

If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage

Keep the medicine in the foil pouch until you are ready to use it. Store at room temperature, away from heat and direct light. Do not freeze.

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Precautions While Using Proventil

It is very important that your doctor check the progress of you or your child at regular visits. This will allow your doctor to see if the medicine is working properly and to check for any unwanted effects.

This medicine should not be used together with other inhaled medicines that are similar, such as isoproterenol (Isuprel®), levalbuterol (Xopenex™), metaproterenol (Alupent®), pirbuterol (Maxair®), or terbutaline (Brethaire®).

This medicine may cause paradoxical bronchospasm, which means your breathing or wheezing will get worse. Paradoxical bronchospasm may be life-threatening. Stop using this medicine and check with your doctor right away if you or your child have coughing, difficulty breathing, shortness of breath, or wheezing after using this medicine.

Talk to your doctor or get medical help right away if:

Your symptoms do not improve or they become worse after using this medicine.

Your inhaler does not seem to be working as well as usual and you need to use it more often.

You or your child may also be taking an antiinflammatory medicine, such as a steroid (cortisone-like medicine), together with this medicine. Do not stop taking the antiinflammatory medicine, even if your asthma seems better, unless you are told to do so by your doctor.

Albuterol may cause serious types of allergic reactions, including anaphylaxis. Anaphylaxis can be life-threatening and requires immediate medical attention. Stop using this medicine and check with your doctor right away if you or your child develop a skin rash, hives, itching, trouble breathing, trouble swallowing, or any swelling of your hands, face, or mouth while you are using this medicine.

Hypokalemia (low potassium in the blood) may occur while you are using this medicine. Check with your doctor right away if you or your child have more than one of the following symptoms: convulsions; decreased urine; dry mouth; increased thirst; irregular heartbeat; loss of appetite; mood changes; muscle pain or cramps; nausea or vomiting; numbness or tingling in the hands, feet, or lips; shortness of breath; or unusual tiredness or weakness.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines for appetite control, asthma, colds, cough, hay fever, or sinus problems, and herbal or vitamin supplements.

Proventil Side Effects

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

More common

Fast, irregular, pounding, or racing heartbeat or pulse

shakiness in the legs, arms, hands, or feet

trembling or shaking of the hands or feet

Less common

Abdominal or stomach pain

bladder pain

bloody or cloudy urine

chest discomfort

chest pain

cough or hoarseness

cough producing mucus

diarrhea

difficult or labored breathing

difficulty with swallowing

dizziness

feeling of warmth

fever or chills

frequent urge to urinate

hives

itching

loss of appetite

lower back or side pain

nausea

puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue

redness of the face, neck, arms, and occasionally, upper chest

runny nose

shortness of breath

skin rash

sore throat

swollen, painful, or tender lymph glands in the neck, armpit, or groin

tightness in the chest

unusual tiredness or weakness

weakness

wheezing

Rare

Hives or welts

large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs

noisy breathing

redness of the skin

swelling of the mouth or throat

trouble breathing

Incidence not known

Agitation

anxiety

arm, back, or jaw pain

chest tightness or heaviness

confusion

convulsions

decreased urine

dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position

drowsiness

dry mouth

extra heartbeats

fainting

flushed, dry skin

fruit-like breath odor

hallucinations

headache

increased hunger

increased thirst

increased urination

irritability

lightheadedness

muscle pain or cramps

nervousness

nightmares

numbness or tingling in the hands, feet, or lips

pounding in the ears

rapid, deep breathing

restlessness

shakiness

slow or fast heartbeat

stomach cramps

sweating

unexplained weight loss

unusual feeling of excitement

vomiting

More common

Body aches or pain

congestion

fever

runny nose

tender, swollen glands in the neck

trouble with swallowing

voice changes

Less common

Difficult, burning, or painful urination

earache

headache, severe and throbbing

muscle or bone pain

pain

redness of the skin

redness or swelling in the ear

redness, swelling, or soreness of the tongue

sleeplessness

sneezing

stuffy nose

swelling

tenderness

trouble in holding or releasing urine

trouble sleeping

unable to sleep

warmth on the skin

Rare

Sleepiness or unusual drowsiness

Incidence not known

Bad, unusual, or unpleasant (after) taste

change in taste

feeling of constant movement of self or surroundings

gagging

rough, scratchy sound to voice

sensation of spinning

tightness in the throat

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

See also: Proventil Inhalation side effects (in more detail)

More Proventil Inhalation resources

Proventil Inhalation Side Effects (in more detail)
Proventil Inhalation Use in Pregnancy & Breastfeeding
Drug Images
Proventil Inhalation Drug Interactions
Proventil Inhalation Support Group
6 Reviews for Proventil Inhalation - Add your own review/rating

Compare Proventil Inhalation with other medications

Asthma, acute
Asthma, Maintenance
Bronchospasm Prophylaxis
COPD, Acute
COPD, Maintenance

Robax Platinum

Robax Platinum may be available in the countries listed below.

Ingredient matches for Robax Platinum

Ibuprofen

Ibuprofen is reported as an ingredient of Robax Platinum in the following countries:

Canada

Methocarbamol

Methocarbamol is reported as an ingredient of Robax Platinum in the following countries:

Canada

International Drug Name Search

Rosacea Medications

Definition of Rosacea: A disorder involving chronic inflammation of the cheeks, nose, chin, forehead, or eyelids; it may cause redness, vascularity (increased prominence of the blood vessels), swelling or hyperplasia (increase in size of the tissue), or skin eruptions similar to acne.

Drugs associated with Rosacea

The following drugs and medications are in some way related to, or used in the treatment of Rosacea. This service should be used as a supplement to, and NOT a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners.