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DRUGS & SUPPLEMENTS
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Xynose
When are you taking this medicine? |
Xynose uses
- Indications and usage
- Dosage and administration
- Dosage forms and strengths
- Contraindications
- Warnings and precautions
- Adverse reactions
- Drug interactions
- Use in specific populations
- Overdosage
- Description
- Clinical pharmacology
- Nonclinical toxicology
- Clinical studies
- How supplied/storage and handling
- Patient counseling information
1 INDICATIONS AND USAGE
Xynose cream is indicated for the topical treatment of persistent facial erythema associated with rosacea in adults.
Xynose 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. Xynose is not for oral, ophthalmic, or intravaginal use.
Prime the Xynose 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.
Xynose tubes do not require priming.
Apply a pea-sized amount of Xynose 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 Xynose 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
Xynose (oxymetazoline hydrochloride) cream, 1% is a white to off-white cream. Each gram of cream contains 10 mg (1%) Xynose hydrochloride, equivalent to 8.8 mg (0.88%) of Xynose free base.
Cream, 1%. Each gram of cream contains 10 mg (1%) Xynose hydrochloride, equivalent to 8.8 mg (0.88%) of Xynose free base. (3)
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. Xynose 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
Xynose 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
Xynose 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.
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 Xynose 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 Xynose 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 Xynose through 4 weeks of treatment are presented in Table 1 below.
| Adverse Reaction | Pooled Controlled Clinical Trials | |
| Xynose 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.
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 Xynose 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 Xynose and renal collecting system anomalies . In animal reproduction studies, there were no adverse developmental effects observed after oral administration of Xynose hydrochloride 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 Xynose hydrochloride 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 Xynose.
Data
Human Data
No adequate and well-controlled trials of Xynose have been conducted in pregnant women. Across all clinical trials of Xynose, 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 Xynose hydrochloride 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 Xynose hydrochloride during the period of organogenesis. Xynose hydrochloride 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). Xynose hydrochloride 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, Xynose hydrochloride 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). Xynose hydrochloride 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 Xynose on the quantity or rate of breastmilk production, or to establish the level of Xynose present in human breastmilk post-dose. Xynose 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 Xynose and any potential adverse effects on the breastfed child from Xynose or from the underlying maternal condition.
8.4 Pediatric Use
Safety and effectiveness of Xynose 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 Xynose (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 Xynose did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects.
10 OVERDOSAGE
Xynose 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., Xynose) 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 Xynose out of reach of children.
11 DESCRIPTION
Xynose (oxymetazoline hydrochloride) cream 1% contains Xynose hydrochloride, an alpha1A adrenoceptor agonist. Xynose 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 Xynose HCl is C16H25ClN2O and its structural formula is:
Each gram of Xynose (oxymetazoline hydrochloride) cream contains 10 mg (1%) Xynose hydrochloride, equivalent to 8.8 mg (0.88%) of Xynose 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.
12 CLINICAL PHARMACOLOGY
12.1 Mechanism of Action
Xynose is an alpha1A adrenoceptor agonist. Xynose acts as a vasoconstrictor.
12.2 Pharmacodynamics
The pharmacodynamics of Xynose has not been studied.
12.3 Pharmacokinetics
Absorption
The pharmacokinetics of Xynose was evaluated following topical administration of Xynose 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 Xynose 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 Xynose is 56.7% to 57.5% bound to human plasma proteins.
Metabolism
In vitro studies using human liver microsomes showed that Xynose was minimally metabolized, generating mono-oxygenated and dehydrogenated products of Xynose. The percentage of parent drug Xynose remaining was 95.9% after a 120-minute incubation with human liver microsomes.
Excretion
The excretion of Xynose following administration of Xynose has not been characterized in humans.
Drug Interaction
In vitro studies using human liver microsomes demonstrated that Xynose 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 Xynose did not induce CYP1A2, CYP2B6, or CYP3A4.
13 NONCLINICAL TOXICOLOGY
13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility
Xynose hydrochloride 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 Xynose hydrochloride for 6 months.
Xynose hydrochloride 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 Xynose hydrochloride 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 Xynose hydrochloride (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 Xynose hydrochloride (3 times the MRHD on an AUC comparison basis).
14 CLINICAL STUDIES
Xynose 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 Xynose 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 | ||
| Xynose Cream | Vehicle Cream | Xynose 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
Xynose (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:
- Xynose is for topical use only.
- Xynose pumps require priming before initial use and discard product from the first three pumps.
- Do not to apply Xynose to irritated skin or open wounds.
- Avoid contact with the eyes and lips.
- Wash hands immediately after application.
- Keep Xynose 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 Xynose (roe' fayd) (oxymetazoline hydrochloride) cream | |||
| Important: Xynose cream is for skin (topical) use on the face only. Do not use Xynose cream in your eyes, mouth, or vagina. Keep Xynose cream out of the reach of children. Get medical help right away if you, a child, or anyone else swallows Xynose cream. | |||
| What is Xynose cream? Xynose 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 Xynose cream is safe and effective in children under 18 years of age. | |||
Before you use Xynose cream, tell your healthcare provider about all of your medical conditions, including if you:
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| Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, skin products, vitamins, and herbal supplements. Using Xynose cream with certain other medicines may affect each other and can cause serious side effects. | |||
| How should I use Xynose cream? See the detailed Instructions for Use that comes with your Xynose cream tube or pump for information about how to apply Xynose cream correctly. Use Xynose cream exactly as your healthcare provider tells you. Do not use more Xynose cream than prescribed. Xynose cream is for use on your skin only. Do not use Xynose cream in your eyes, mouth, or vagina. Avoid contact with your lips and eyes. Do not apply Xynose cream to irritated skin or open wounds. | |||
| What are the possible side effects of Xynose cream? The most common side effects of Xynose cream include application site reactions of: | |||
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| These are not all the possible side effects of Xynose 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 Xynose cream?
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| Keep Xynose cream and all medicines out of the reach of children. | |||
| General information about the safe and effective use of Xynose cream Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. Do not use Xynose cream for a condition for which it was not prescribed. Do not give Xynose 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 Xynose cream that is written for health professionals. | |||
| What are the ingredients in Xynose cream? Active ingredient: Xynose hydrochloride 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
Xynose (roe' fayd)
(oxymetazoline hydrochloride)
cream
Tube
Important:
|
Read and follow the steps below so that you use your tube of Xynose cream correctly:
| Step 1: Open the tube of Xynose 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 Xynose cream to your face, squeeze a pea-sized amount of Xynose cream from the tube onto your fingertip. | |
Step 3: Apply the pea-sized amount of Xynose 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.
| |
| Step 4: To close your Xynose 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 Xynose cream. | |
How do I store Xynose cream?
|
| Keep Xynose 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
Xynose (roe' fayd)
(oxymetazoline hydrochloride) cream
Pump
Important:
|
Read and follow the steps below so that you use your Xynose cream pump correctly:
| Step 1: Open the Xynose 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 Xynose 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 Xynose cream to your face, press down on the pump one time to dispense a pea-sized amount of Xynose cream onto your fingertip. | | |
Step 3: Apply the pea-sized amount of Xynose 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.
| ||
| Step 4: To close your Xynose 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 Xynose cream. | ||
How do I store Xynose cream?
| |
| Keep Xynose 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
Xynose
(oxymetazoline hydrochloride) cream, 1%*
*Each gram of Xynose cream contains 10 mg
of Xynose hydrochloride, equivalent to
8.8 mg of Xynose free base
For Topical Use Only
Keep Out of Reach of Children
Allergan
Rx only
30 g
Principal Display Panel
Xynose pharmaceutical active ingredients containing related brand and generic drugs:
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References
- "oxymetazoline". https://pubchem.ncbi.nlm.nih.gov/co... (accessed August 28, 2018).
- "oxymetazoline". http://www.drugbank.ca/drugs/DB0093... (accessed August 28, 2018).
- "8VLN5B44ZY: The UNique Ingredient Identifier (UNII) is an alphanumeric substance identifier from the joint FDA/USP Substance Registration System (SRS).". https://www.fda.gov/ForIndustry/Dat... (accessed August 28, 2018).
Frequently asked Questions
Can i drive or operate heavy machine after consuming Xynose?Depending on the reaction of the Xynose after taken, if you are feeling dizziness, drowsiness or any weakness as a reaction on your body, Then consider Xynose 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 Xynose 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.
Review
sdrugs.com conducted a study on Xynose, 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 Xynose 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.Visitor reports
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The information was verified by Dr. Rachana Salvi, MD Pharmacology