Duramist Plus Up to 12 Hour Nasal Decongestant Spray

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Duramist Plus Up to 12 Hour Nasal Decongestant Spray uses


1 INDICATIONS AND USAGE

Duramist Plus Up to 12 Hour Nasal Decongestant Spray cream is indicated for the topical treatment of persistent facial erythema associated with rosacea in adults.

Duramist Plus Up to 12 Hour Nasal Decongestant Spray is an alpha1A adrenoceptor agonist indicated for the topical treatment of persistent facial erythema associated with rosacea in adults. (1)

2 DOSAGE AND ADMINISTRATION

For topical use only. Duramist Plus Up to 12 Hour Nasal Decongestant Spray is not for oral, ophthalmic, or intravaginal use.

Prime the Duramist Plus Up to 12 Hour Nasal Decongestant Spray pump before using for the first time. To do so, with the pump in the upright position, repeatedly depress the actuator until cream is dispensed and then pump three times. Discard the cream from priming actuations. It is only necessary to prime the pump before the first dose.

Duramist Plus Up to 12 Hour Nasal Decongestant Spray tubes do not require priming.

Apply a pea-sized amount of Duramist Plus Up to 12 Hour Nasal Decongestant Spray cream, once daily in a thin layer to cover the entire face (forehead, nose, each cheek, and chin) avoiding the eyes and lips. Wash hands immediately after applying Duramist Plus Up to 12 Hour Nasal Decongestant Spray cream.

  • Not for oral, ophthalmic, or intravaginal use. (2)
  • Prime pump bottle before initial use and discard product from first three pumps. (2)
  • Apply a pea-sized amount once daily in a thin layer to cover the entire face (forehead, nose, each cheek, and chin) avoiding the eyes and lips. (2)
  • Wash hands after application. (2)

3 DOSAGE FORMS AND STRENGTHS

Duramist Plus Up to 12 Hour Nasal Decongestant Spray (oxymetazoline hydrochloride) cream, 1% is a white to off-white cream. Each gram of cream contains 10 mg (1%) Duramist Plus Up to 12 Hour Nasal Decongestant Spray, equivalent to 8.8 mg (0.88%) of oxymetazoline free base.

Cream, 1%. Each gram of cream contains 10 mg (1%) Duramist Plus Up to 12 Hour Nasal Decongestant Spray, equivalent to 8.8 mg (0.88%) of oxymetazoline free base. (3)

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4 CONTRAINDICATIONS

None.

  • None. (4)

5 WARNINGS AND PRECAUTIONS

  • Alpha-adrenergic agonists as a class may impact blood pressure. Advise patients with cardiovascular disease, orthostatic hypotension, and/or uncontrolled hypertension or hypotension to seek medical care if their condition worsens.
  • Use with caution in patients with cerebral or coronary insufficiency, Raynaud's phenomenon, thromboangiitis obliterans, scleroderma, or Sjögren's syndrome and advise patients to seek medical care if signs and symptoms of potentiation of vascular insufficiency develop. (5.2)
  • Advise patients to seek immediate medical care if signs and symptoms of acute narrow-angle glaucoma develop. (5.3)

5.1 Potential Impacts on Cardiovascular Disease

Alpha-adrenergic agonists may impact blood pressure. Duramist Plus Up to 12 Hour Nasal Decongestant Spray should be used with caution in patients with severe or unstable or uncontrolled cardiovascular disease, orthostatic hypotension, and uncontrolled hypertension or hypotension. Advise patients with cardiovascular disease, orthostatic hypotension, and/or uncontrolled hypertension/hypotension to seek immediate medical care if their condition worsens.

5.2 Potentiation of Vascular Insufficiency

Duramist Plus Up to 12 Hour Nasal Decongestant Spray should be used with caution in patients with cerebral or coronary insufficiency, Raynaud's phenomenon, thromboangiitis obliterans, scleroderma, or Sjögren's syndrome. Advise patients to seek immediate medical care if signs and symptoms of potentiation of vascular insufficiency develop.

5.3 Risk of Angle Closure Glaucoma

Duramist Plus Up to 12 Hour Nasal Decongestant Spray may increase the risk of angle closure glaucoma in patients with narrow-angle glaucoma. Advise patients to seek immediate medical care if signs and symptoms of acute angle closure glaucoma develop.

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6 ADVERSE REACTIONS

Most common adverse reactions are application site dermatitis, worsening inflammatory lesions of rosacea, application site pruritis, application site erythema, and application site pain. (6.1)

To report SUSPECTED ADVERSE REACTIONS, contact Allergan at 1-800-433-8871 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

6.1 Clinical Studies Experience

Because clinical trials are conducted under 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 practice.

A total of 489 subjects with persistent facial erythema associated with rosacea were treated with Duramist Plus Up to 12 Hour Nasal Decongestant Spray once daily for 4 weeks in 3 controlled clinical trials. An additional 440 subjects with persistent facial erythema associated with rosacea were also treated with Duramist Plus Up to 12 Hour Nasal Decongestant Spray once daily for up to one year in a long-term (open-label) clinical trial. Adverse reactions that occurred in at least 1% of subjects treated with Duramist Plus Up to 12 Hour Nasal Decongestant Spray through 4 weeks of treatment are presented in Table 1 below.

Adverse Reaction Pooled Controlled

Clinical Trials

Duramist Plus Up to 12 Hour Nasal Decongestant Spray Cream

(N = 489)

Vehicle Cream

(N = 483)

Application site dermatitis 9 (2%) 0
Worsening inflammatory lesions of rosacea 7 (1%) 1 (<1%)
Application site pruritus 5 (1%) 4 (1%)
Application site erythema 5 (1%) 2 (<1%)
Application site pain 4 (1%) 1 (<1%)

In the long-term (open-label) clinical trial, the rates of adverse reactions over a one-year treatment period were as follows: worsening inflammatory lesions of rosacea (3%), application site dermatitis (3%), application site pruritis (2%), application site pain (2%), and application site erythema (2%). Subjects with persistent erythema along with inflammatory lesions were allowed to use additional therapy for the inflammatory lesions of rosacea.

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7 DRUG INTERACTIONS

7.1 Anti-hypertensives/Cardiac Glycosides

Alpha-adrenergic agonists, as a class, may impact blood pressure. Caution in using drugs such as beta-blockers, anti-hypertensives and/or cardiac glycosides is advised.

Caution should also be exercised in patients receiving alpha1 adrenergic receptor antagonists such as in the treatment of cardiovascular disease, benign prostatic hypertrophy, or Raynaud's disease.

7.2 Monoamine Oxidase Inhibitors

Caution is advised in patients taking MAO inhibitors which can affect the metabolism and uptake of circulating amines.

8 USE IN SPECIFIC POPULATIONS

8.1 Pregnancy

Risk Summary

There are no available data on Duramist Plus Up to 12 Hour Nasal Decongestant Spray use in pregnant women to inform a drug-associated risk for major birth defects and miscarriage. A literature article describing intranasal decongestant use in pregnant women identified a potential association between second-trimester exposure to oxymetazoline and renal collecting system anomalies . In animal reproduction studies, there were no adverse developmental effects observed after oral administration of Duramist Plus Up to 12 Hour Nasal Decongestant Spray in pregnant rats and rabbits at systemic exposures up to 3 times and 73 times, respectively, the exposure associated with the maximum recommended human dose (MRHD) . The estimated background risks of major birth defects and miscarriage for the indicated population are unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2-4% and 15-20%, respectively.

Clinical Considerations

Fetal/Neonatal Adverse Reactions

Following repeated use of Duramist Plus Up to 12 Hour Nasal Decongestant Spray solution nasal spray for the treatment of nasal congestion at a dose 5 times higher than recommended, one case of fetal distress was reported in a 41-week pregnant patient. The fetal distress resolved hours later, prior to the delivery of the healthy infant. The anticipated exposures for the case are 8- to18-fold higher than plasma exposures after topical administration of Duramist Plus Up to 12 Hour Nasal Decongestant Spray.

Data

Human Data

No adequate and well-controlled trials of Duramist Plus Up to 12 Hour Nasal Decongestant Spray have been conducted in pregnant women. Across all clinical trials of Duramist Plus Up to 12 Hour Nasal Decongestant Spray, two pregnancies were reported. One pregnancy resulted in the delivery of a healthy child. One pregnancy resulted in a spontaneous abortion, which was considered to be unrelated to the trial medication. A literature article summarizing the results of exploratory analyses of intranasal decongestant use during pregnancy identified a potential association between second-trimester exposure to Duramist Plus Up to 12 Hour Nasal Decongestant Spray solution (with no decongestant exposure in the first trimester) and renal collecting system anomalies.

Animal Data

Effects on embryo-fetal development were evaluated in rats and rabbits following oral administration of Duramist Plus Up to 12 Hour Nasal Decongestant Spray during the period of organogenesis. Duramist Plus Up to 12 Hour Nasal Decongestant Spray did not cause adverse effects to the fetus at oral doses up to 0.2 mg/kg/day in pregnant rats during the period of organogeneisis (3 times the MRHD on an AUC comparison basis). Duramist Plus Up to 12 Hour Nasal Decongestant Spray did not cause adverse effects to the fetus at oral doses up to 1 mg/kg/day in pregnant rabbits during the period of organogeneisis (73 times the MRHD on an AUC comparison basis). Maternal toxicity, such as decreased maternal body weight, was produced at the high dose of 1 mg/kg/day in pregnant rabbits and was associated with findings of delayed skeletal ossification.

In a rat perinatal and postnatal development study, Duramist Plus Up to 12 Hour Nasal Decongestant Spray was orally administered to pregnant rats once daily from gestation day 6 through lactation day 20. Maternal toxicity was produced at the high dose of 0.2 mg/kg/day (3 times the MRHD on an AUC comparison basis) in pregnant rats and was associated with an increase in pup mortality and reduced pup body weights. Delayed sexual maturation was noted at 0.1 and 0.2 mg/kg/day (2 times the MRHD and 3 times the MRHD on an AUC comparison basis, respectively). Duramist Plus Up to 12 Hour Nasal Decongestant Spray did not have any adverse effects on fetal development at a dose of 0.05 mg/kg/day (one-half of the MRHD on an AUC comparison basis).

8.2 Lactation

No clinical data are available to assess the effects of oxymetazoline on the quantity or rate of breastmilk production, or to establish the level of oxymetazoline present in human breastmilk post-dose. Oxymetazoline was detected in the milk of lactating rats. The developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for Duramist Plus Up to 12 Hour Nasal Decongestant Spray and any potential adverse effects on the breastfed child from Duramist Plus Up to 12 Hour Nasal Decongestant Spray or from the underlying maternal condition.

8.4 Pediatric Use

Safety and effectiveness of Duramist Plus Up to 12 Hour Nasal Decongestant Spray have not been established in pediatric patients below the age of 18 years.

8.5 Geriatric Use

One hundred and ninety-three subjects aged 65 years and older received treatment with Duramist Plus Up to 12 Hour Nasal Decongestant Spray (n = 135) or vehicle (n = 58) in clinical trials. No overall differences in safety or effectiveness were observed between subjects≥ 65 years of age and younger subjects, based on available data. Clinical studies of Duramist Plus Up to 12 Hour Nasal Decongestant Spray did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects.

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10 OVERDOSAGE

Duramist Plus Up to 12 Hour Nasal Decongestant Spray is not for oral use. If oral ingestion occurs, seek medical advice. Monitor patient closely and administer appropriate supportive measures as necessary. Accidental ingestion of topical solutions (nasal sprays) containing imidazoline derivatives (e.g., oxymetazoline) in children has resulted in serious adverse events requiring hospitalization, including nausea, vomiting, lethargy, tachycardia, decreased respiration, bradycardia, hypotension, hypertension, sedation, somnolence, mydriasis, stupor, hypothermia, drooling, and coma. Keep Duramist Plus Up to 12 Hour Nasal Decongestant Spray out of reach of children.

11 DESCRIPTION

Duramist Plus Up to 12 Hour Nasal Decongestant Spray (oxymetazoline hydrochloride) cream 1% contains Duramist Plus Up to 12 Hour Nasal Decongestant Spray, an alpha1A adrenoceptor agonist. Duramist Plus Up to 12 Hour Nasal Decongestant Spray is a white to off-white cream. It has a chemical name of 3-[(4,5-Dihydro-1H-imidazol-2-yl)methyl]-6-(1,1-dimethylethyl)-2,4-dimethyl-phenol hydrochloride and a molecular weight of 296.8. It is freely soluble in water and ethanol and has a partition coefficient of 0.1 in 1-octanol/water. The molecular formula of oxymetazoline HCl is C16H25ClN2O and its structural formula is:

Each gram of Duramist Plus Up to 12 Hour Nasal Decongestant Spray (oxymetazoline hydrochloride) cream contains 10 mg (1%) Duramist Plus Up to 12 Hour Nasal Decongestant Spray, equivalent to 8.8 mg (0.88%) of oxymetazoline free base. The cream contains the following inactive ingredients: sodium citrate dihydrate, citric acid anhydrous, disodium edetate dihydrate, butylated hydroxytoluene, anhydrous lanolin, medium chain triglycerides, diisopropyl adipate, oleyl alcohol, polyethylene glycol 300, PEG-6 stearate, glycol stearate, PEG-32 stearate, cetostearyl alcohol, ceteareth-6, stearyl alcohol, ceteareth-25, methylparaben, propylparaben, phenoxyethanol, and purified water.

Structural Formula

12 CLINICAL PHARMACOLOGY

12.1 Mechanism of Action

Oxymetazoline is an alpha1A adrenoceptor agonist. Oxymetazoline acts as a vasoconstrictor.

12.2 Pharmacodynamics

The pharmacodynamics of Duramist Plus Up to 12 Hour Nasal Decongestant Spray has not been studied.

12.3 Pharmacokinetics

Absorption

The pharmacokinetics of oxymetazoline was evaluated following topical administration of Duramist Plus Up to 12 Hour Nasal Decongestant Spray in a thin layer to cover the entire face in adult subjects with erythema associated with rosacea. The median weight of cream for each dose administration was 0.3 g. Plasma oxymetazoline concentrations were measurable in most of the subjects. Following the first dose application, the mean ± standard deviation (SD) peak concentrations (Cmax) and area under the concentration-time curves from time 0 to 24 hours (AUC0-24hr) were 60.5 ± 53.9 pg/mL and 895 ±798 pg*hr/mL, respectively. Following once daily applications for 28 days, the mean ± SD Cmax and AUC0-24hr were 66.4 ± 67.1 pg/mL and 1050 ± 992 pg*hr/mL, respectively. Following twice daily applications (twice the recommended frequency of application) for 28 days, the mean ± SD Cmax and AUC0-24hr were 68.8 ± 61.1 pg/mL and 1530 ± 922 pg*hr/mL, respectively.

Distribution

An in vitro study demonstrated that oxymetazoline is 56.7% to 57.5% bound to human plasma proteins.

Metabolism

In vitro studies using human liver microsomes showed that oxymetazoline was minimally metabolized, generating mono-oxygenated and dehydrogenated products of oxymetazoline. The percentage of parent drug oxymetazoline remaining was 95.9% after a 120-minute incubation with human liver microsomes.

Excretion

The excretion of oxymetazoline following administration of Duramist Plus Up to 12 Hour Nasal Decongestant Spray has not been characterized in humans.

Drug Interaction

In vitro studies using human liver microsomes demonstrated that oxymetazoline up to the tested concentration of 100 nM had no inhibition on the activities of the cytochrome P450 (CYP) isoenzymes 1A2, 2B6, 2C8, 2C9, 2C19, 2D6, and 3A4/5. Treatment of cultured human hepatocytes with up to 100 nM oxymetazoline did not induce CYP1A2, CYP2B6, or CYP3A4.

13 NONCLINICAL TOXICOLOGY

13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility

Duramist Plus Up to 12 Hour Nasal Decongestant Spray was not associated with an increased incidence of neoplastic or proliferative changes in transgenic mice given oral doses of 0.5, 1.0, or 2.5 mg/kg/day Duramist Plus Up to 12 Hour Nasal Decongestant Spray for 6 months.

Duramist Plus Up to 12 Hour Nasal Decongestant Spray revealed no evidence of mutagenic or clastogenic potential based on the results of two in vitro genotoxicity tests (Ames assay and human lymphocyte chromosomal aberration assay) and one in vivo gentoxicity test (mouse micronucleus assay).

Effects on fertility and early embryonic development were evaluated in rats following oral administration of 0.05, 0.1, or 0.2 mg/kg/day Duramist Plus Up to 12 Hour Nasal Decongestant Spray prior to and during mating and through early pregnancy. Decreased number of corpora lutea and increased post-implantation losses were noted at 0.2 mg/kg/day Duramist Plus Up to 12 Hour Nasal Decongestant Spray (3 times the MRHD on an AUC comparison basis). However, no treatment related effects on fertility or mating parameters were noted at 0.2 mg/kg/day Duramist Plus Up to 12 Hour Nasal Decongestant Spray (3 times the MRHD on an AUC comparison basis).

14 CLINICAL STUDIES

Duramist Plus Up to 12 Hour Nasal Decongestant Spray was evaluated for the treatment of persistent erythema associated with rosacea in two identical, randomized, double-blind, vehicle-controlled, parallel-group clinical trials. The trials enrolled 885 subjects aged 18 years and older. Overall, 90% of subjects were Caucasian and 79% were female. Subjects applied either Duramist Plus Up to 12 Hour Nasal Decongestant Spray or vehicle once daily for 29 days.

Disease severity was graded by the clinician using a 5-point clinician erythema assessment (CEA) scale and by the subject on a similar 5-point subject self-assessment (SSA) scale, on which subjects scored either “moderate” or “severe” on both scales.

CEA and SSA were measured over a 12-hour period at equally-spaced timepoints (hours 3, 6, 9, and 12) post-dose on Days 1, 15, and 29. The primary efficacy endpoint was defined as the proportion of subjects with at least a 2-grade reduction in erythema (improvement) from baseline (pre-dose on Day 1) on both the CEA and SSA measured at hours 3, 6, 9, and 12 on Day 29. The results from both trials on the composite endpoint for Day 29 are presented in Table 2.

Time-point

(Hour)

Trial 1 Trial 2
Duramist Plus Up to 12 Hour Nasal Decongestant Spray Cream Vehicle Cream Duramist Plus Up to 12 Hour Nasal Decongestant Spray Cream Vehicle Cream
(N=222) (N=218) (N = 224) (N=221)
3 12% 6% 14% 7%
6 16% 8% 13% 5%
9 18% 6% 16% 9%
12 15% 6% 12% 6%

*Composite success is defined as the proportion of subjects achieving at least a 2-grade improvement on both CEA and SSA.

16 HOW SUPPLIED/STORAGE AND HANDLING

Duramist Plus Up to 12 Hour Nasal Decongestant Spray (oxymetazoline hydrochloride) cream, 1%, is a white to off-white cream. The product is available in a laminated tube and an airless pump polypropylene bottle in the following packaging configurations, each with a child-resistant closure:

NDC 0023-5300-30 30 gram tube

NDC 0023-5300-60 60 gram tube

NDC 0023-5300-35 30 gram pump

NDC 0023-5300-65 60 gram pump

Storage: Store at 20°C-25°C (68°F-77°F); excursions permitted to 15°C-30ºC (59°F-86ºF).

17 PATIENT COUNSELING INFORMATION

Advise the patient and/or caregiver to read the FDA-approved patient labeling (Patient Information and Instructions for Use).

Important Administration Instructions

Advise patients of the following:

  • Duramist Plus Up to 12 Hour Nasal Decongestant Spray is for topical use only.
  • Duramist Plus Up to 12 Hour Nasal Decongestant Spray pumps require priming before initial use and discard product from the first three pumps.
  • Do not to apply Duramist Plus Up to 12 Hour Nasal Decongestant Spray to irritated skin or open wounds.
  • Avoid contact with the eyes and lips.
  • Wash hands immediately after application.
  • Keep Duramist Plus Up to 12 Hour Nasal Decongestant Spray out of reach of children.

Manufactured for Allergan, Irvine, CA 92612, U.S.A.

by DPT Laboratories, Ltd, San Antonio, TX 78215

© 2017 Allergan. All rights reserved.

Irvine, CA 92612

All trademarks are the property of their respective owners.

Patented. See www.allergan.com/patents

Made in the U.S.A.

73141US10

Logo

This Patient Information has been approved by the U.S. Food and Drug Administration

Approved: 01/2017

PATIENT INFORMATION

Duramist Plus Up to 12 Hour Nasal Decongestant Spray (roe' fayd)

(oxymetazoline hydrochloride)

cream

Important: Duramist Plus Up to 12 Hour Nasal Decongestant Spray cream is for skin (topical) use on the face only. Do not use Duramist Plus Up to 12 Hour Nasal Decongestant Spray cream in your eyes, mouth, or vagina.

Keep Duramist Plus Up to 12 Hour Nasal Decongestant Spray cream out of the reach of children.

Get medical help right away if you, a child, or anyone else swallows Duramist Plus Up to 12 Hour Nasal Decongestant Spray cream.

What is Duramist Plus Up to 12 Hour Nasal Decongestant Spray cream?

Duramist Plus Up to 12 Hour Nasal Decongestant Spray cream is a prescription medicine used on the skin (topical) to treat facial redness due to rosacea that does not go away (persistent) in adults.

It is not known if Duramist Plus Up to 12 Hour Nasal Decongestant Spray cream is safe and effective in children under 18 years of age.

Before you use Duramist Plus Up to 12 Hour Nasal Decongestant Spray cream, tell your healthcare provider about all of your medical conditions, including if you:

  • have heart, blood vessel, or blood pressure problems. Call your healthcare provider or get medical help if these conditions worsen.
  • have problems with blood circulation or have had a stroke
  • have Sjögren's Syndrome
  • have scleroderma
  • have Raynaud's phenomenon
  • have thromboangiitis obliterans
  • have narrow-angle glaucoma. Call your healthcare provider or get medical help if your glaucoma worsens.
  • have irritated skin or open sores on the face

  • are pregnant or plan to become pregnant. It is not known if Duramist Plus Up to 12 Hour Nasal Decongestant Spray cream will harm your unborn baby.
  • are breastfeeding. It is not known if Duramist Plus Up to 12 Hour Nasal Decongestant Spray cream passes into your breast milk. Talk to your healthcare provider about the best way to feed your baby if you use Duramist Plus Up to 12 Hour Nasal Decongestant Spray cream.

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, skin products, vitamins, and herbal supplements. Using Duramist Plus Up to 12 Hour Nasal Decongestant Spray cream with certain other medicines may affect each other and can cause serious side effects.
How should I use Duramist Plus Up to 12 Hour Nasal Decongestant Spray cream?

See the detailed Instructions for Use that comes with your Duramist Plus Up to 12 Hour Nasal Decongestant Spray cream tube or pump for information about how to apply Duramist Plus Up to 12 Hour Nasal Decongestant Spray cream correctly.

Use Duramist Plus Up to 12 Hour Nasal Decongestant Spray cream exactly as your healthcare provider tells you. Do not use more Duramist Plus Up to 12 Hour Nasal Decongestant Spray cream than prescribed.

Duramist Plus Up to 12 Hour Nasal Decongestant Spray cream is for use on your skin only. Do not use Duramist Plus Up to 12 Hour Nasal Decongestant Spray cream in your eyes, mouth, or vagina. Avoid contact with your lips and eyes.

Do not apply Duramist Plus Up to 12 Hour Nasal Decongestant Spray cream to irritated skin or open wounds.

What are the possible side effects of Duramist Plus Up to 12 Hour Nasal Decongestant Spray cream?

The most common side effects of Duramist Plus Up to 12 Hour Nasal Decongestant Spray cream include application site reactions of:

  • skin reactions (dermatitis)
  • worsening of rosacea pimples
  • itching
  • redness
  • pain
These are not all the possible side effects of Duramist Plus Up to 12 Hour Nasal Decongestant Spray cream.

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

How should I store Duramist Plus Up to 12 Hour Nasal Decongestant Spray cream?

  • Store Duramist Plus Up to 12 Hour Nasal Decongestant Spray cream at room temperature between 68°F to 77°F (20°C to 25°C).

Keep Duramist Plus Up to 12 Hour Nasal Decongestant Spray cream and all medicines out of the reach of children.
General information about the safe and effective use of Duramist Plus Up to 12 Hour Nasal Decongestant Spray cream

Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. Do not use Duramist Plus Up to 12 Hour Nasal Decongestant Spray cream for a condition for which it was not prescribed. Do not give Duramist Plus Up to 12 Hour Nasal Decongestant Spray cream to other people, even if they have the same symptoms that you have. It may harm them. You can ask your pharmacist or healthcare provider for information about Duramist Plus Up to 12 Hour Nasal Decongestant Spray cream that is written for health professionals.

What are the ingredients in Duramist Plus Up to 12 Hour Nasal Decongestant Spray cream?

Active ingredient: Duramist Plus Up to 12 Hour Nasal Decongestant Spray

Inactive ingredients: sodium citrate dihydrate, citric acid anhydrous, disodium edetate dihydrate, butylated hydroxytoluene, anhydrous lanolin, medium chain triglycerides, diisopropyl adipate, oleyl alcohol, polyethylene glycol 300, PEG-6 stearate, glycol stearate, PEG-32 stearate, cetostearyl alcohol, ceteareth-6, stearyl alcohol, ceteareth-25, methylparaben, propylparaben, phenoxyethanol, and purified water


Manufactured for Allergan, Irvine, CA 92612, U.S.A.

by DPT Laboratories, Ltd, San Antonio, TX 78215

© 2017 Allergan. All rights reserved. Irvine, CA 92612, U.S.A.

All trademarks are the property of their respective owners. Patented. See www.allergan.com/patents.

Made in the U.S.A.



73141US10

INSTRUCTIONS FOR USE

Duramist Plus Up to 12 Hour Nasal Decongestant Spray (roe' fayd)

(oxymetazoline hydrochloride)

cream

Tube

Important:

  • Duramist Plus Up to 12 Hour Nasal Decongestant Spray cream is for skin (topical) use on the face only. Do not use Duramist Plus Up to 12 Hour Nasal Decongestant Spray cream in your eyes, mouth, or vagina.
  • Keep Duramist Plus Up to 12 Hour Nasal Decongestant Spray cream out of the reach of children.
  • Get medical help right away if you, a child, or anyone else swallows Duramist Plus Up to 12 Hour Nasal Decongestant Spray cream.

Read and follow the steps below so that you use your tube of Duramist Plus Up to 12 Hour Nasal Decongestant Spray cream correctly:

Step 1: Open the tube of Duramist Plus Up to 12 Hour Nasal Decongestant Spray cream by gently pressing down on the child-resistant cap and twisting it counterclockwise until the cap is removed. Do not squeeze the tube while opening or closing.

Note: When the cap is removed, the tube is not child-resistant.


Step 2: To apply Duramist Plus Up to 12 Hour Nasal Decongestant Spray cream to your face, squeeze a pea-sized amount of Duramist Plus Up to 12 Hour Nasal Decongestant Spray cream from the tube onto your fingertip.
Step 3: Apply the pea-sized amount of Duramist Plus Up to 12 Hour Nasal Decongestant Spray cream to cover your entire face (forehead, nose, each cheek, and chin) 1 time each day. Spread the cream smoothly and evenly in a thin layer over your face.

  • Avoid contact with your eyes and lips.
  • Do not apply cream to irritated skin or open wounds.
Step 4: To close your Duramist Plus Up to 12 Hour Nasal Decongestant Spray cream tube, place the cap back on the tube. Press down on the child-resistant cap and twist clockwise until it stops. The tube is child-resistant again.

Step 5: Wash your hands right away after applying Duramist Plus Up to 12 Hour Nasal Decongestant Spray cream.
How do I store Duramist Plus Up to 12 Hour Nasal Decongestant Spray cream?

  • Store Duramist Plus Up to 12 Hour Nasal Decongestant Spray cream at room temperature between 68°F to 77°F (20°C to 25°C).

Keep Duramist Plus Up to 12 Hour Nasal Decongestant Spray cream and all medicines out of the reach of children.

This Instructions for Use has been approved by the U.S. Food and Drug Administration.

Manufactured for Allergan, Irvine, CA 92612, U.S.A.

by DPT Laboratories, Ltd, San Antonio, TX 78215

© 2017 Allergan. All rights reserved. Irvine, CA 92612, U.S.A.

All trademarks are the property of their respective owners.

Patented. See www.allergan.com/patents. Made in the U.S.A.

Approved: 01/2017

73141US10

Figure Figure Figure Figure

INSTRUCTIONS FOR USE

Duramist Plus Up to 12 Hour Nasal Decongestant Spray (roe' fayd)

(oxymetazoline hydrochloride) cream

Pump

Important:

  • Duramist Plus Up to 12 Hour Nasal Decongestant Spray cream is for skin (topical) use on the face only. Do not use Duramist Plus Up to 12 Hour Nasal Decongestant Spray cream in your eyes, mouth, or vagina.
  • Keep Duramist Plus Up to 12 Hour Nasal Decongestant Spray cream out of the reach of children.
  • Get medical help right away if you, a child, or anyone else swallows Duramist Plus Up to 12 Hour Nasal Decongestant Spray cream.

Read and follow the steps below so that you use your Duramist Plus Up to 12 Hour Nasal Decongestant Spray cream pump correctly:

Step 1: Open the Duramist Plus Up to 12 Hour Nasal Decongestant Spray cream pump by pushing down on the child-resistant cap and twisting it counterclockwise until the cap is removed. The clear sticker will break when opening for the first time.

Note: When the cap is removed, the pump is not child-resistant.


Prime your Duramist Plus Up to 12 Hour Nasal Decongestant Spray cream pump before the first use only. Hold the pump upright and press down several times until the cream is dispensed onto a tissue. Pump 3 more times onto the tissue and throw away (discard) the tissue.

Your pump is now ready to use.


Step 2: To apply Duramist Plus Up to 12 Hour Nasal Decongestant Spray cream to your face, press down on the pump one time to dispense a pea-sized amount of Duramist Plus Up to 12 Hour Nasal Decongestant Spray cream onto your fingertip.

Step 3: Apply the pea-sized amount of Duramist Plus Up to 12 Hour Nasal Decongestant Spray cream to cover your entire face (forehead, nose, each cheek, and chin) 1 time each day. Spread the cream smoothly and evenly in a thin layer over your face.

  • Avoid contact with your eyes and lips.
  • Do not apply Duramist Plus Up to 12 Hour Nasal Decongestant Spray cream to irritated skin or open wounds.
Step 4: To close your Duramist Plus Up to 12 Hour Nasal Decongestant Spray cream pump, place the cap back on the pump. Push down on the child-resistant cap and turn the cap clockwise until it stops. The pump is child-resistant again.

Step 5: Wash your hands right away after applying Duramist Plus Up to 12 Hour Nasal Decongestant Spray cream.
How do I store Duramist Plus Up to 12 Hour Nasal Decongestant Spray cream?

  • Store Duramist Plus Up to 12 Hour Nasal Decongestant Spray cream at room temperature between 68°F to 77°F (20°C to 25°C).

Keep Duramist Plus Up to 12 Hour Nasal Decongestant Spray cream and all medicines out of the reach of children.

This Instructions for Use has been approved by the U.S. Food and Drug Administration.

Manufactured for Allergan, Irvine, CA 92612, U.S.A.

by DPT Laboratories, Ltd, San Antonio, TX 78215

© 2017 Allergan. All rights reserved. Irvine, CA 92612, U.S.A.

All trademarks are the property of their respective owners.

Patented. See www.allergan.com/patents. Made in the U.S.A.

Approved: 01/2017

73141US10

Figure Figure Figure Figure Figure

NDC 0023-5300-30

Duramist Plus Up to 12 Hour Nasal Decongestant Spray

(oxymetazoline hydrochloride) cream, 1%*

*Each gram of Duramist Plus Up to 12 Hour Nasal Decongestant Spray cream contains 10 mg

of Duramist Plus Up to 12 Hour Nasal Decongestant Spray, equivalent to

8.8 mg of oxymetazoline free base

For Topical Use Only

Keep Out of Reach of Children

Allergan

Rx only

30 g

Principal Display Panel

Duramist Plus Up to 12 Hour Nasal Decongestant Spray pharmaceutical active ingredients containing related brand and generic drugs:

Active ingredient is the part of the drug or medicine which is biologically active. This portion of the drug is responsible for the main action of the drug which is intended to cure or reduce the symptom or disease. The other portions of the drug which are inactive are called excipients; there role is to act as vehicle or binder. In contrast to active ingredient, the inactive ingredient's role is not significant in the cure or treatment of the disease. There can be one or more active ingredients in a drug.


Duramist Plus Up to 12 Hour Nasal Decongestant Spray available forms, composition, doses:

Form of the medicine is the form in which the medicine is marketed in the market, for example, a medicine X can be in the form of capsule or the form of chewable tablet or the form of tablet. Sometimes same medicine can be available as injection form. Each medicine cannot be in all forms but can be marketed in 1, 2, or 3 forms which the pharmaceutical company decided based on various background research results.
Composition is the list of ingredients which combinedly form a medicine. Both active ingredients and inactive ingredients form the composition. The active ingredient gives the desired therapeutic effect whereas the inactive ingredient helps in making the medicine stable.
Doses are various strengths of the medicine like 10mg, 20mg, 30mg and so on. Each medicine comes in various doses which is decided by the manufacturer, that is, pharmaceutical company. The dose is decided on the severity of the symptom or disease.


Duramist Plus Up to 12 Hour Nasal Decongestant Spray destination | category:

Destination is defined as the organism to which the drug or medicine is targeted. For most of the drugs what we discuss, human is the drug destination.
Drug category can be defined as major classification of the drug. For example, an antihistaminic or an antipyretic or anti anginal or pain killer, anti-inflammatory or so.


Duramist Plus Up to 12 Hour Nasal Decongestant Spray Anatomical Therapeutic Chemical codes:

A medicine is classified depending on the organ or system it acts [Anatomical], based on what result it gives on what disease, symptom [Therapeutical], based on chemical composition [Chemical]. It is called as ATC code. The code is based on Active ingredients of the medicine. A medicine can have different codes as sometimes it acts on different organs for different indications. Same way, different brands with same active ingredients and same indications can have same ATC code.


Duramist Plus Up to 12 Hour Nasal Decongestant Spray pharmaceutical companies:

Pharmaceutical companies are drug manufacturing companies that help in complete development of the drug from the background research to formation, clinical trials, release of the drug into the market and marketing of the drug.
Researchers are the persons who are responsible for the scientific research and is responsible for all the background clinical trials that resulted in the development of the drug.


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References

  1. Dailymed."RHOFADE (OXYMETAZOLINE HYDROCHLORIDE) CREAM [ALLERGAN]". https://dailymed.nlm.nih.gov/dailym... (accessed August 28, 2018).
  2. "oxymetazoline". https://pubchem.ncbi.nlm.nih.gov/co... (accessed August 28, 2018).
  3. "oxymetazoline". http://www.drugbank.ca/drugs/DB0093... (accessed August 28, 2018).

Frequently asked Questions

Can i drive or operate heavy machine after consuming Duramist Plus Up to 12 Hour Nasal Decongestant Spray?

Depending on the reaction of the Duramist Plus Up to 12 Hour Nasal Decongestant Spray after taken, if you are feeling dizziness, drowsiness or any weakness as a reaction on your body, Then consider Duramist Plus Up to 12 Hour Nasal Decongestant Spray 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 Duramist Plus Up to 12 Hour Nasal Decongestant Spray 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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Review

sdrugs.com conducted a study on Duramist Plus Up to 12 Hour Nasal Decongestant Spray, and the result of the survey is set out below. It is noteworthy that the product of the survey is based on the perception and impressions of the visitors of the website as well as the views of Duramist Plus Up to 12 Hour Nasal Decongestant Spray consumers. We, as a result of this, advice that you do not base your therapeutic or medical decisions on this result, but rather consult your certified medical experts for their recommendations.

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The information was verified by Dr. Arunabha Ray, MD Pharmacology

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