4/29/2020
`
`DUONASE Nasal Spray | CiplaMed
`
`HOME (/HOME)
`
`SPECIALITY
`
`TOPICS
`
`SCIENTIFIC RESOURCES
`
`PRODUCT INDEX (/PRODUCT-INDEX-LISTING)
`
`INFOGRAPHICS (/INFOGRAPHICS)
`
`HOME (/HOME)
`
`SPECIALITY
`
`TOPICS
`
`SCIENTIFIC RESOURCES
`
`PRODUCT INDEX (/PRODUCT-INDEX-LISTING)
`
`INFOGRAPHICS (/INFOGRAPHICS)
`
` (/)
`
`Specialties
`
`Search
`
`
`
`Login (/user/login)
`
`Register (/user/register)
`
`https://www.ciplamed.com/content/duonase-nasal-spray
`
`1/13
`
`CIPLA LTD. EXHIBIT 2007 PAGE 1
`
`

`

`4/29/2020
`
`DUONASE Nasal Spray | CiplaMed
`
`New Content (/new_content)
`
`Medical News (/medical-news-list)
`
`eCMEs (/webcast-listing)
`
`Scientic Resources
`
`Topics
`
`Infographics (/infographics)
`
`Product Index (/product-index-listing)
`
`Medico-Legal (/webcast-listing-councel)
`
`Home (https://www.ciplamed.com) » Respiratory Medicine (/category/specialty/23) » Product Index (/product-index-
`listing)
`
`Product Index
`
`DUONASE Nasal Spray (Azelastine hydrochloride +
`Fluticasone propionate)
`
`DUONASE Nasal Spray (/content/duonase-
`nasal-spray)
`
`Duonase nasal spray is a combination of INCS
`(Fluticasone
`propionate)
`and
`topical
`antihistamine
`(Azelastine), used
`in
`the
`management of allergic rhinitis in patients ≥ 12
`(https://ciplamedprod.blob.core.windows.net/ciplawebcast/Brand
`years. 
`Card
`Duonase
`nasal spray vers 4-
`01.jpg)
`Infographic
`(https://ciplamedprod.blob.core.windows.net/ciplawebcast/Brand
`Card
`Duonase
`nasal spray vers 4-
`01.jpg)
`
`Composition
`
`https://www.ciplamed.com/content/duonase-nasal-spray
`
`2/13
`
`Featured Content
`
`CIPLA LTD. EXHIBIT 2007 PAGE 2
`
`

`

`4/29/2020
`
`DUONASE Nasal Spray | CiplaMed
`
`DUONASE Nasal Spray
`
`Each spray delivers:
`
`Azelastine Hydrochloride BP …… 140 mcg
`
`Fluticasone Propionate BP ……… 50 mcg
`
`Fluticasone Propionate BP ……. 0.0357% w/v
`
`Azelastine Hydrochloride BP ….0.10% w/v
`
`Benzalkonium Chloride NF ……0.01% w/v (as preservative)
`
`Dosage Form
`
`Intranasal spray
`
`Description
`
`is an antihistamine-corticosteroid combination
`DUONASE Nasal Spray
`available as a metered spray formulation for intranasal administration. It
`contains azelastine hydrochloride, which is a second generation H receptor-
`1
`antagonist with potent topical activity, and uticasone propionate, a
`synthetic corticosteroid with anti-inammatory properties.
`
`Pharmacology
`
`As DUONASE Nasal Spray is a combination of azelastine hydrochloride and
`uticasone propionate,
`the pharmacological properties of both
`the
`molecules are given separately.
`
`Pharmacodynamics
`
`Azelastine Hydrochloride
`
`Azelastine hydrochloride, a phthalazinone derivative, exhibits histamine H
`1
`receptor- antagonist activity in isolated tissues, animal models, and humans.
`The major metabolite, desmethylazelastine, also possesses H receptor-
`1
`antagonist activity.
`
`There was no evidence of cardiac repolarization (represented as corrected
`QT interval) after administration of azelastine hydrochloride nasal spray (2
`sprays per nostril) in 56-day placebo-controlled trial with 95 patients with
`
`https://www.ciplamed.com/content/duonase-nasal-spray
`
`3/13
`
`Infants with PPHN
`Burdened with
`Increased Morbidity
`and...
`(https://ciplamed.com/content/inf
`with-pphn-burdened-
`with-increased-
`morbidity-and-
`mortality-risk-in-the-
`rst-year-of)
`
`Migraine and Elevated
`IOP Increase the Risk
`of Low Ocular...
`(https://ciplamed.com/content/mig
`and-elevated-iop-
`increase-the-risk-of-
`low-ocular-perfusion-
`pressure-may-
`associate)
`
`VERIFY: Early
`Vildagliptin and
`Metformin
`Combination...
`(https://ciplamed.com/content/ver
`early-vildagliptin-and-
`metformin-
`combination-therapy-
`associated-with-
`greater-and-lo-0)
`
`CIPLA LTD. EXHIBIT 2007 PAGE 3
`
`

`

`4/29/2020
`
`DUONASE Nasal Spray | CiplaMed
`
`allergic rhinitis.
`
`Following multiple dose oral administration of azelastine 4 mg or 8 mg twice
`daily, the mean change in QTc was 7.2 msec and 3.6 msec, respectively.
`
`investigating the cardiac repolarization effects of
`Interaction studies
`concomitantly administered oral azelastine hydrochloride and erythromycin
`or ketoconazole were conducted. These drugs had no effect on QTc based
`on analysis of serial electrocardiograms.
`
`Fluticasone Propionate
`
`Fluticasone propionate is a synthetic, triuorinated corticosteroid with anti-
`inammatory activity.
`
`In pre-clinical studies, uticasone propionate revealed progesterone-like
`activity similar to the natural hormone. However, the clinical signicance of
`these ndings in relation to the low plasma levels is not known.
`
`The precise mechanism through which uticasone propionate affects
`allergic rhinitis symptoms is not known. Corticosteroids have been shown to
`have a wide range of effects on multiple cell types (e.g., mast cells,
`eosinophils, neutrophils, macrophages, and lymphocytes) and mediators
`(e.g., histamine, eicosanoids,
`leukotrienes, and cytokines)
`involved
`in
`inammation.
`
`Pharmacokinetics
`
`Absorption: After intranasal administration of two sprays per nostril (548
`mcg of azelastine hydrochloride and 200 mcg of uticasone) of azelastine
`hydrochloride and uticasone propionate combination nasal spray, the mean
`(± standard deviation) peak plasma exposure (Cmax) was 194.5 ± 74.4
`pg/mL for azelastine and 10.3±3.9 pg/mL for uticasone propionate and the
`mean total exposure (AUC) was 4217 ± 2618 pg/mL*hr for azelastine and
`97.7 ± 43.1 pg/mL*hr for uticasone. The median time to peak exposure
`(t
`) from a single dose was 0.5 hours for azelastine and 1.0 hours for
`max
`uticasone.
`
`Systemic bioavailability of azelastine from azelastine hydrochloride and
`uticasone propionate combination nasal spray following
`intranasal
`administration was comparable with monotherapy azelastine hydrochloride
`nasal spray (i.e., approximately 40%). Systemic bioavailability of uticasone
`from azelastine hydrochloride and uticasone propionate combination nasal
`spray
`following
`intranasal administration was 44-61% higher
`than
`
`https://www.ciplamed.com/content/duonase-nasal-spray
`
`4/13
`
`CIPLA LTD. EXHIBIT 2007 PAGE 4
`
`

`

`4/29/2020
`
`DUONASE Nasal Spray | CiplaMed
`
`for monotherapy
`(bioavailability
`monotherapy uticasone propionate
`uticasone nasal spray was less than 2%). Due to the low intranasal
`bioavailability, pharmacokinetic data for uticasone propionate were
`obtained via other routes of administration. Studies using oral dosing of
`radiolabeled uticasone propionate showed negligible oral bioavailability
`and high extraction from plasma. The majority of the circulating radioactivity
`was due to an inactive metabolite.
`
`Distribution: Based on intravenous and oral administration, the steady-state
`volume of distribution of azelastine hydrochloride is 14.5 L/kg. In vitro
`studies with human plasma indicate that the plasma protein binding of
`azelastine hydrochloride and
`its metabolite, desmethylazelastine, are
`approximately 88% and 97%, respectively.
`
`initial disposition phase for
`intravenous administration, the
`Following
`uticasone propionate was rapid and consistent with its high lipid solubility
`and tissue binding. The volume of distribution averaged 4.2 L/kg.
`
`The percentage of uticasone propionate bound to human plasma proteins
`averaged 91% with no obvious concentration relationship. Fluticasone
`propionate is weakly and reversibly bound to erythrocytes and freely
`equilibrates between erythrocytes and plasma. Fluticasone propionate is not
`signicantly bound to human transcortin.
`
`Metabolism: Azelastine hydrochloride is oxidatively metabolized to the
`principal active metabolite, desmethylazelastine, by the cytochrome P450
`enzyme system. The specic P450
`isoforms
`responsible
`for
`the
`biotransformation of azelastine have not been identied. The total clearance
`of azelastine is approximately 0.50 L/kg/hr. For uticasone propionate, the
`only circulating metabolite detected in man is the 17_-carboxylic acid
`derivative, which is formed through the CYP3A4 pathway. This inactive
`metabolite had less anity (approximately 1/2,000) than the parent drug for
`the glucocorticoid receptor of human lung cytosol in vitro and negligible
`pharmacological activity in animal studies. Other metabolites detected in
`vitro using cultured human hepatoma cells have not been detected in man.
`The average total clearance of uticasone propionate is relatively high
`(approximately 66 L/hr).
`
`Elimination: Following intranasal administration of azelastine hydrochloride
`and uticasone propionate combination nasal spray, the elimination half-life
`of azelastine hydrochloride is approximately 25 hours. Approximately 75% of
`
`https://www.ciplamed.com/content/duonase-nasal-spray
`
`5/13
`
`CIPLA LTD. EXHIBIT 2007 PAGE 5
`
`

`

`4/29/2020
`
`DUONASE Nasal Spray | CiplaMed
`
`an oral dose of radiolabeled azelastine hydrochloride was excreted in the
`feces with less than 10% as unchanged azelastine.
`
`showed
`propionate
`uticasone
`dosing,
`intravenous
`Following
`polyexponential kinetics and had a terminal elimination half-life of
`approximately 7.8 hours. Less than 5% of a radiolabeled oral dose was
`excreted in the urine as metabolites, with the remainder excreted in the feces
`as parent drug and metabolites.
`
`Indications
`
`DUONASE Nasal Spray is indicated for the management of symptoms of
`allergic rhinitis, once the need for an antihistamine and corticosteroid has
`been established. It is recommended for the treatment of moderate to
`severe persistent symptoms in adults and adolescents above 6 years of age.
`
`Dosage And Administration
`
`Adults/Adolescents (Above 6 years of age)
`
`One spray/nostril twice daily.
`
`The recommended dosage should not be exceeded.
`
`Contraindications
`
`in patients with known
`is contraindicated
`DUONASE Nasal Spray
`hypersensitivity to azelastine hydrochloride or uticasone propionate or any
`of the components of the preparation.
`
`Warnings And Precautions
`
`In clinical trials, the occurrence of somnolence has been reported in some
`patients (6 of 853 patients) taking azelastine hydrochloride and uticasone
`propionate combination nasal spray. Patients should be cautioned against
`engaging in hazardous occupations requiring complete mental alertness and
`motor coordination such as operating machinery or driving a motor vehicle
`after administration of azelastine hydrochloride and uticasone propionate
`combination nasal spray. Concurrent use of this combination with alcohol or
`
`https://www.ciplamed.com/content/duonase-nasal-spray
`
`6/13
`
`CIPLA LTD. EXHIBIT 2007 PAGE 6
`
`

`

`4/29/2020
`
`DUONASE Nasal Spray | CiplaMed
`
`other central nervous system (CNS) depressants or other antihistamines
`should be avoided as additional reductions in alertness and additional
`impairment of CNS performance may occur.
`
`In clinical trials of 2 to 52 weeks’ duration, epistaxis was observed more
`frequently in patients treated with azelastine hydrochloride and uticasone
`propionate combination nasal spray. Instances of nasal ulceration and nasal
`septal perforation have been reported in patients following the intranasal
`application of corticosteroids. There were no instances of nasal ulceration or
`nasal septal perforation observed
`in clinical
`trials with azelastine
`hydrochloride and uticasone propionate combination nasal spray.
`
`Because of the inhibitory effect of corticosteroids on wound healing,
`patients who have experienced recent nasal ulcers, nasal surgery, or nasal
`trauma should not use azelastine hydrochloride and uticasone propionate
`combination nasal spray until healing has occurred.
`
`In clinical trials with uticasone propionate administered intranasally, the
`development of localized infections of the nose and pharynx with Candida
`albicans has occurred. When such an infection develops, it may require
`treatment with appropriate local therapy and discontinuation of treatment
`with the combination. Patients using DUONASE over several months or
`longer should be examined periodically for evidence of Candida infection or
`other signs of adverse effects on the nasal mucosa.
`
`The replacement of a systemic corticosteroid with a topical corticosteroid
`can be accompanied by signs of adrenal insuciency. Some patients may
`experience symptoms of withdrawal, e.g., joint and/or muscular pain,
`lassitude, and depression. Patients previously treated for prolonged periods
`with systemic corticosteroids and transferred to topical corticosteroids
`should be carefully monitored for acute adrenal insuciency in response to
`stress. In those patients who have asthma or other clinical conditions
`requiring long term systemic corticosteroid treatment, too rapid a decrease
`in systemic corticosteroids may cause a severe exacerbation of their
`symptoms.
`
`When intranasal steroids are used at higher than recommended dosages or
`in susceptible individuals at recommended dosages, systemic corticosteroid
`effects such as hypercorticism and adrenal suppression may appear. If such
`changes occur, the dosage of DUONASE Nasal Spray should be discontinued
`slowly, consistent with accepted procedures for discontinuing oral
`corticosteroid therapy. The concomitant use of an intranasal corticosteroid
`
`https://www.ciplamed.com/content/duonase-nasal-spray
`
`7/13
`
`CIPLA LTD. EXHIBIT 2007 PAGE 7
`
`

`

`4/29/2020
`
`DUONASE Nasal Spray | CiplaMed
`
`with other corticosteroids could increase the risk of signs or symptoms of
`hypercorticism and/or suppression of the HPA-axis. Therefore, such a
`combination should be used cautiously in patients with other pathological
`conditions requiring steroids.
`
`Intranasal corticosteroids may cause a reduction in growth velocity when
`administered at higher dose. The recommended dosage of DUONASE Nasal
`Spray should not be exceeded.
`
`Persons who are using drugs, such as corticosteroids, that suppress the
`immune system are more susceptible to infections than healthy individuals.
`In children or adults who have not had these diseases or been properly
`immunized, particular care should be taken to avoid exposure. How the dose,
`route, and duration of corticosteroid administration affect the risk of
`developing a disseminated infection is not known. The contribution of the
`underlying disease and/or prior corticosteroid treatment to the risk is also
`not known. If exposed to chickenpox, prophylaxis with varicella zoster
`immune globulin (VZIG) may be
`indicated.
`If exposed to measles,
`prophylaxis with pooled
`intramuscular
`immunoglobulin (IG) may be
`indicated. (See the respective package inserts for complete VZIG and IG
`prescribing information.) If chickenpox develops, treatment with antiviral
`agents may be considered.
`
`Corticosteroids should be used with caution, if at all, in patients with active
`or quiescent tuberculous infections of the respiratory tract; untreated local or
`systemic fungal or bacterial infections; systemic viral or parasitic infections;
`or ocular herpes simplex because of the potential for worsening of these
`infections.
`
`long-term therapy, monitoring of haematological and adrenal
`During
`functions is advisable.
`
`Nasal and inhaled corticosteroids may result in the development of
`glaucoma and/or cataracts. Therefore, close monitoring is warranted in
`patients with a change in vision or with a history of increased intraocular
`pressure, glaucoma, and/or cataracts.
`
`In clinical trials with uticasone propionate administered intranasally, the
`development of localized infections of the nose and pharynx with Candida
`albicans has occurred. When such an infection develops, it may require
`treatment with appropriate local therapy and discontinuation of treatment
`
`https://www.ciplamed.com/content/duonase-nasal-spray
`
`8/13
`
`CIPLA LTD. EXHIBIT 2007 PAGE 8
`
`

`

`4/29/2020
`
`DUONASE Nasal Spray | CiplaMed
`
`with DUONASE Nasal Spray. Patients using DUONASE Nasal Spray over
`several months or longer should be examined periodically for evidence of
`Candida infection or other signs of adverse effects on the nasal mucosa.
`
`Drug Interactions
`
`Caution should be exercised when DUONASE Nasal Spray is coadministered
`with ketoconazole and other known strong CYP3A4 inhibitors. Ritonavir and
`other strong cytochrome P450 3A4 (CYP3A4) inhibitors can signicantly
`increase plasma uticasone propionate exposure, resulting in signicantly
`reduced serum cortisol concentrations. During post-marketing use, there
`have been reports of clinically signicant drug interactions in patients
`receiving uticasone propionate and ritonavir, resulting
`in systemic
`corticosteroid effects. Co-treatment with other CYP 3A4 inhibitors, including
`cobicistat-containing products is also expected to increase the risk of
`systemic side effects. The combination should be avoided unless the benet
`outweighs the increased risk of systemic corticosteroid side-effects, in
`which case patients should be monitored for systemic corticosteroid side
`effects.
`
`Concurrent use of DUONASE Nasal Spray with alcohol or other central
`nervous system depressants should be avoided because somnolence and
`impairment of central nervous system performance may occur.
`
`Pregnancy
`
`Pregnancy Category C: There are no adequate and well-controlled clinical
`trials of azelastine hydrochloride and uticasone propionate combination
`nasal spray, azelastine hydrochloride only, or uticasone propionate only in
`pregnant women. Animal reproductive studies of azelastine hydrochloride
`and uticasone propionate in mice, rats, and/or rabbits revealed evidence of
`teratogenicity as well as other developmental toxic effects. Because animal
`reproduction studies are not always predictive of human response,
`DUONASE Nasal Spray should be used during pregnancy only if the potential
`benet justies the potential risk to the foetus.
`
`Lactation
`
`It is not known whether azelastine hydrochloride or uticasone propionate is
`excreted in human milk. Because many drugs are excreted in human milk,
`caution should be exercised while prescribing this combination to nursing
`mothers.
`
`https://www.ciplamed.com/content/duonase-nasal-spray
`
`9/13
`
`CIPLA LTD. EXHIBIT 2007 PAGE 9
`
`

`

`4/29/2020
`
`DUONASE Nasal Spray | CiplaMed
`
`Pediatric Use
`
`Safety and effectiveness of azelastine hydrochloride and uticasone
`propionate combination nasal spray in pediatric patients below the age of 12
`years have not been established.
`
`Geriatric Use
`
`Clinical trials of azelastine hydrochloride and uticasone propionate
`combination nasal spray did not include sucient numbers of patients 65
`years of age and older to determine whether they respond differently from
`younger patients. Other reported clinical experience has not identied
`differences in responses between the elderly and younger patients. In
`general, dose selection for an elderly patient should be cautious, usually
`starting at the low end of the dosing range, reecting the greater frequency
`of decreased hepatic, renal, or cardiac function, and of concomitant disease
`or other drug therapy.
`
`Undesirable Effects
`
`Systemic and local corticosteroid use may result in the following:
`
`Somnolence
`Local nasal effects, including epistaxis, nasal ulceration, nasal septal
`perforation, impaired wound healing, and Candida albicans infection.
`Glaucoma and cataracts
`Immunosuppression
`Hypothalamic-pituitary-adrenal (HPA) axis effects, including growth
`reduction
`
`In placebo- controlled randomized clinical studies of two week duration with
`853 adults and adolescents ≥ 12 years of age and suffering from seasonal
`allergic rhinitis treated with azelastine hydrochloride and uticasone
`propionate combination nasal spray, the adverse reactions with ≥ 2%
`incidence or more frequently than placebo were: headache (2% versus 1%
`placebo), dysgeusia (4% versus <1% placebo) and epistaxis (2% versus 2%
`placebo). Somnolence was reported in <1% of patients treated with
`azelastine hydrochloride and uticasone propionate combination nasal
`spray in these trials.
`
`In long term open-label studies of 12-month duration with 404 patients
`treated with azelastine hydrochloride and uticasone propionate
`combination nasal spray  with perennial allergic rhinitis or vasomotor rhinitis
`
`https://www.ciplamed.com/content/duonase-nasal-spray
`
`10/13
`
`CIPLA LTD. EXHIBIT 2007 PAGE 10
`
`

`

`4/29/2020
`
`DUONASE Nasal Spray | CiplaMed
`
`the most frequently (≥ 2%) reported adverse reactions were headache,
`pyrexia, cough, nasal congestion, rhinitis, dysgeusia, viral infection, upper
`respiratory tract infection, pharyngitis, pain, diarrhea, and epistaxis.
`
`The following spontaneous adverse events have been reported during the
`marketing of azelastine hydrochloride nasal spray and causal relationship
`with the drug is unknown: anaphylactoid reaction, application site irritation,
`atrial brillation,
`increased heart rate, chest pain, anxiety, confusion,
`nervousness,  dyspnea, facial edema, involuntary muscle contractions, nasal
`sores, palpitations, paresthesia, parosmia, pruritus, rash, disturbance or loss
`of sense of smell and/or taste, tolerance, urinary retention, vision abnormal
`and xerophthalmia.
`
`In addition, the following events have been identied during post-approval
`use of uticasone propionate nasal spray. These events have been chosen
`for inclusion due to either their seriousness, frequency of reporting, or causal
`connection to uticasone propionate or a combination of these factors.
`
`General: Hypersensitivity reactions, including angioedema, erythema, skin
`rash, edema of the face and tongue, pruritus, urticaria, bronchospasm,
`wheezing, dyspnea, and anaphylaxis/anaphylactoid reactions, which in rare
`instances were severe. Other general effects could be aches and pain,
`application site irritation, chest pain, edema of face and tongue, fatigue,
`tolerance.
`
`Ear, Nose, and Throat: Alteration or loss of sense of taste and/or smell and,
`rarely, nasal septal perforation, nasal ulcer, sore throat, throat irritation and
`dryness, cough, hoarseness, dysphonia and voice changes.
`
`Eye: Dryness and irritation, conjunctivitis, blurred vision, glaucoma, eye
`swelling, vision abnormal, increased intraocular pressure, and cataracts.
`Visual disturbance may be reported with systemic and topical corticosteroid
`use. If a patient presents with symptoms such as blurred vision or other
`visual disturbances, the patient should be considered for referral to an
`ophthalmologist for evaluation of possible causes which may include
`cataract, glaucoma or
`rare diseases such as central serous
`chorioretinopathy (CSCR) which have been reported after use of systemic
`and topical corticosteroids.
`
`Cases of growth suppression have been
`corticosteroids, including uticasone propionate.
`
`reported
`
`for
`
`intranasal
`
`https://www.ciplamed.com/content/duonase-nasal-spray
`
`11/13
`
`CIPLA LTD. EXHIBIT 2007 PAGE 11
`
`

`

`4/29/2020
`
`DUONASE Nasal Spray | CiplaMed
`
`Because these reactions are reported voluntarily from a population of
`uncertain size, it is not always possible to reliably estimate their frequency or
`establish a causal relationship to drug exposure.
`
`The other adverse events could include: hypertension, dizziness, sneezing,
`nasal discomfort, nasal dryness, mucosal erosion, nausea, vomiting and
`fatigue.
`
`In rare cases osteoporosis was observed, if nasal glucocorticoids were
`administered long-term.
`
`If you experience any side effects, talk to your doctor or pharmacist or write
`to drugsafety@cipla.com (mailto:drugsafety@cipla.com). You can also
`report side effects directly via the national pharmacovigilance program of
`India by calling on 1800 180 3024.
`
`Overdosage
`
`Azelastine Hydrochloride
`
`There have been no reported overdosages with azelastine hydrochloride.
`Acute azelastine hydrochloride overdosage by adults with this dosage form
`is unlikely to result in clinically signicant adverse events, other than
`increased somnolence. Clinical trials in adults with single doses of the oral
`formulation of azelastine hydrochloride (up to 16 mg) have not resulted in
`increased incidence of serious adverse events. General supportive measures
`should be employed if overdosage occurs. There is no known antidote to
`azelastine hydrochloride and uticasone propionate combination nasal
`spray.
`
`Fluticasone Propionate
`
`Use of excessive doses of corticosteroids and/or chronic overdosage may
`lead to signs or symptoms of hypercorticism and/or suppression of the HPA
`function.
`
`Intranasal administration of 2  mg (10 times the recommended dose) of
`uticasone propionate, twice daily for 7 days, to healthy human volunteers
`was well tolerated. Single oral doses of up to 16 mg have been studied in
`human volunteers with no acute toxic effects reported. Repeat oral doses of
`up to 80 mg daily for 10 days in volunteers and repeat oral doses of up to
`10 mg daily for 14 days in patients were also well tolerated.
`
`https://www.ciplamed.com/content/duonase-nasal-spray
`
`12/13
`
`CIPLA LTD. EXHIBIT 2007 PAGE 12
`
`

`

`4/29/2020
`
`DUONASE Nasal Spray | CiplaMed
`
`Packaging Information
`
`DUONASE Nasal Spray
`
`Sales pack contains 70 metered doses
`
`Last Updated: March 2018
`
`Last Reviewed: March 2018
`
`Device Demos
`(/device-
`demo)
`Product Index
`(/product-
`index-listing)
`PG Quiz (/pg-
`quiz-listing)
`Journals
`(/journal-list)
`
`Useful Links
`(/usefullinks-
`list)
`Calendar
`(/event-
`listing-page)
`Most Popular
`(/most-
`populars)
`
`New Content
`(/new_content)
`Expert's
`Views
`(/expert-
`viewpoint-
`listing)
`Guidelines
`(/guidelines-
`listing)
`Clinical Tools
`(/clinical-
`tools-list)
`
`|
`CONTACT US (/contactus-nonregistered)
`ABOUT US (/about-us)
`| SITEMAP (/sitemap)
`PRIVACY POLICY (/privacy-policy)
`|
`DISCLAIMER (/disclaimer)
`
`|
`
`© Copyright 2020 -- All rights reserved  
`
`Connect with Us
`Subscribe to Ciplamed
`Newsletter
`
`Enter your email id
`
`Subscribe
`
`WWW.CIPLA.COM (http://www.cipla.com/) |
`WWW.BREATHEFREE.COM
`(http://www.breathefree.com/)
`
`Get the App
`
`
`
`https://www.ciplamed.com/content/duonase-nasal-spray
`
`13/13
`
`CIPLA LTD. EXHIBIT 2007 PAGE 13
`
`