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| Product NDC Code | 70382-204 | ||||||||
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| Drug Name | Dextenza |
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| Type | Brand | ||||||||
| Pharm Class | Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC] |
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| Active Ingredients |
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| Route | INTRACANALICULAR, OPHTHALMIC | ||||||||
| Dosage Form | INSERT | ||||||||
| RxCUI drug identifier | 2108015, 2108020 |
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| Application Number | NDA208742 | ||||||||
| Labeler Name | Ocular Therapeutix, Inc. | ||||||||
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Adverse reactions
Information about undesirable effects, reasonably associated with use of the drug, that may occur as part of the pharmacological action of the drug or may be unpredictable in its occurrence. Adverse reactions include those that occur with the drug, and if applicable, with drugs in the same pharmacologically active and chemically related class. There is considerable variation in the listing of adverse reactions. They may be categorized by organ system, by severity of reaction, by frequency, by toxicological mechanism, or by a combination of these.6 ADVERSE REACTIONS The following serious adverse reactions are described elsewhere in the labeling: Intraocular Pressure Increase [see Warnings and Precautions ( 5.1 )] Bacterial Infection [see Warnings and Precautions ( 5.2 )] Viral Infection [see Warnings and Precautions ( 5.3 )] Fungal Infection [see Warnings and Precautions ( 5.4 )] Delayed Healing [see Warnings and Precautions ( 5.5 )] The most commonly reported adverse reactions were anterior chamber inflammation and elevations in intraocular pressure. These occurred in approximately 6-10% of patients ( 6 ). To report SUSPECTED ADVERSE REACTIONS, contact Ocular Therapeutix at 1-800-DEXTENZA (339-8369) or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch . 6.1 Clinical Trials Experience Because clinical trials are conducted under widely 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. Adverse reactions associated with ophthalmic steroids include elevated intraocular pressure, which may be associated with optic nerve damage, visual acuity and field defects, posterior subcapsular cataract formation; delayed wound healing; secondary ocular infection from pathogens including herpes simplex, and perforation of the globe where there is thinning of the cornea or sclera [see Warnings and Precautions ( 5 )] . 6.2 Ocular Inflammation and Pain Following Ophthalmic Surgery DEXTENZA safety was studied in four randomized, vehicle-controlled studies (n = 567). The mean age of the population was 68 years (range 35 to 87 years), 59% were female, and 83% were white. Forty-seven percent had brown iris color and 30% had blue iris color. The most common ocular adverse reactions that occurred in patients treated with DEXTENZA were: anterior chamber inflammation including iritis and iridocyclitis (10%); intraocular pressure increased (6%); visual acuity reduced (2%); cystoid macular edema (1%); corneal edema (1%); eye pain (1%) and conjunctival hyperemia (1%). The most common non-ocular adverse reaction that occurred in patients treated with DEXTENZA was headache (1%). 6.3 Itching Associated with Allergic Conjunctivitis DEXTENZA safety was studied in four randomized, vehicle-controlled studies (n= 154). The mean age of the population was 41 years (range 19 to 69 years), 55 % were female and 61 % were white. Fifty seven percent had brown iris color and 20% had blue iris color. The most common ocular adverse reactions that occurred in patients treated with DEXTENZA were: intraocular pressure increased (3%), lacrimation increased (1%), eye discharge (1%), and visual acuity reduced (1%). The most common non-ocular adverse reaction that occurred in patients treated with DEXTENZA was headache (1%).
Clinical pharmacology
Information about the clinical pharmacology and actions of the drug in humans.12 CLINICAL PHARMACOLOGY 12.1 Mechanism of Action Dexamethasone, a corticosteroid, has been shown to suppress inflammation by inhibiting multiple inflammatory cytokines resulting in decreased edema, fibrin deposition, capillary leakage and migration of inflammatory cells. 12.3 Pharmacokinetics Plasma samples were obtained from 16 healthy volunteers prior to insertion of DEXTENZA and on Day 1 (at 1, 2, 4, 8, 16 hours), 2 (24 hours), 4, 8, 15, 22 and 29 following the insertion of DEXTENZA. Plasma concentrations of dexamethasone were detectable (above 50 pg/mL, the lower limit of quantification of the assay) in 11% of samples (21 of 189), and ranged from 0.05 ng/mL to 0.81 ng/mL.
Mechanism of action
Information about the established mechanism(s) of the drugÕs action in humans at various levels (for example receptor, membrane, tissue, organ, whole body). If the mechanism of action is not known, this field contains a statement about the lack of information.12.1 Mechanism of Action Dexamethasone, a corticosteroid, has been shown to suppress inflammation by inhibiting multiple inflammatory cytokines resulting in decreased edema, fibrin deposition, capillary leakage and migration of inflammatory cells.
Pharmacokinetics
Information about the clinically significant pharmacokinetics of a drug or active metabolites, for instance pertinent absorption, distribution, metabolism, and excretion parameters.12.3 Pharmacokinetics Plasma samples were obtained from 16 healthy volunteers prior to insertion of DEXTENZA and on Day 1 (at 1, 2, 4, 8, 16 hours), 2 (24 hours), 4, 8, 15, 22 and 29 following the insertion of DEXTENZA. Plasma concentrations of dexamethasone were detectable (above 50 pg/mL, the lower limit of quantification of the assay) in 11% of samples (21 of 189), and ranged from 0.05 ng/mL to 0.81 ng/mL.
Contraindications
Information about situations in which the drug product is contraindicated or should not be used because the risk of use clearly outweighs any possible benefit, including the type and nature of reactions that have been reported.4 CONTRAINDICATIONS DEXTENZA is contraindicated in patients with active corneal, conjunctival or canalicular infections, including epithelial herpes simplex keratitis (dendritic keratitis), vaccinia, varicella; mycobacterial infections; fungal diseases of the eye, and dacryocystitis. Active ocular infections ( 4 ).
Description
General information about the drug product, including the proprietary and established name of the drug, the type of dosage form and route of administration to which the label applies, qualitative and quantitative ingredient information, the pharmacologic or therapeutic class of the drug, and the chemical name and structural formula of the drug.11 DESCRIPTION DEXTENZA (dexamethasone ophthalmic insert) is a fluorescent yellow, 3 mm cylindrical-shaped, resorbable, sterile insert for intracanalicular use. DEXTENZA contains 0.4 mg dexamethasone in a polyethylene glycol (PEG) based hydrogel conjugated with fluorescein. DEXTENZA does not contain an antimicrobial preservative. The active ingredient is represented by the chemical structure: The chemical name for dexamethasone is 9-Fluoro-11β,17,21-trihydroxy-16α-methylpregna-1,4-diene-3,20-dione. It has a molecular formula of C 22 H 29 FO 5 and a molecular weight of 392.47 g/mol. Dexamethasone is a crystalline powder. Each DEXTENZA contains: Active ingredients: 0.4 mg dexamethasone. Inactive ingredients: 4-arm polyethylene glycol (PEG) N-hydroxysuccinimidyl glutarate (20K), trilysine acetate, N-hydroxysuccinimide-fluorescein, sodium phosphate dibasic, sodium phosphate monobasic, water for injection. Chemical Structure
Dosage and administration
Information about the drug product’s dosage and administration recommendations, including starting dose, dose range, titration regimens, and any other clinically sigificant information that affects dosing recommendations.2 DOSAGE AND ADMINISTRATION DEXTENZA is an ophthalmic insert that is inserted in the lower lacrimal punctum and into the canaliculus. A single DEXTENZA releases a 0.4 mg dose of dexamethasone for up to 30 days following insertion ( 2 ). 2.1 General Dosing Information DEXTENZA is an ophthalmic insert that is inserted in the lower lacrimal punctum into the canaliculus. A single DEXTENZA insert releases a 0.4 mg dose of dexamethasone for up to 30 days following insertion. DEXTENZA is resorbable and does not require removal. Saline irrigation or manual expression can be performed to remove the insert if necessary. DEXTENZA is intended for single-use only. 2.2 Administration Do not use if pouch has been damaged or opened. Do not re-sterilize. Carefully remove foam carrier and transfer to a clean and dry area. If necessary, dilate the punctum with an ophthalmic dilator. Care should be taken not to perforate the canaliculus during dilation or insertion of DEXTENZA. If perforation occurs, do not insert DEXTENZA. After drying the punctal area, using blunt (non-toothed) forceps, grasp DEXTENZA and insert into the lower lacrimal canaliculus by pulling the lid temporally and inserting nasally. Ensure DEXTENZA is placed just below the punctal opening. Excessive squeezing of DEXTENZA with forceps may cause deformation. To aid in the hydration of DEXTENZA, 1 to 2 drops of balanced salt solution can be instilled into the punctum. DEXTENZA hydrates quickly upon contact with moisture. If DEXTENZA begins to hydrate before fully inserted, discard the product and use a new DEXTENZA. DEXTENZA can be visualized when illuminated by a blue light source (e.g., slit lamp or hand held blue light) with yellow filter.
Dosage forms and strengths
Information about all available dosage forms and strengths for the drug product to which the labeling applies. This field may contain descriptions of product appearance.3 DOSAGE FORMS AND STRENGTHS Ophthalmic insert: fluorescent yellow, 3 mm cylindrical-shaped insert containing dexamethasone, 0.4 mg. Ophthalmic intracanalicular insert containing a 0.4 mg dose of dexamethasone ( 3 ).
Indications and usage
A statement of each of the drug products indications for use, such as for the treatment, prevention, mitigation, cure, or diagnosis of a disease or condition, or of a manifestation of a recognized disease or condition, or for the relief of symptoms associated with a recognized disease or condition. This field may also describe any relevant limitations of use.1 INDICATIONS AND USAGE DEXTENZA ® is a corticosteroid indicated for: The treatment of ocular inflammation and pain following ophthalmic surgery ( 1.1 ). The treatment of ocular itching associated with allergic conjunctivitis ( 1.2 ). 1.1 Ocular Inflammation and Pain Following Ophthalmic Surgery DEXTENZA ® (dexamethasone ophthalmic insert) is a corticosteroid indicated for the treatment of ocular inflammation and pain following ophthalmic surgery ( 1.1 ). 1.2 Itching Associated with Allergic Conjunctivitis DEXTENZA ® (dexamethasone ophthalmic insert) is a corticosteroid indicated for the treatment of ocular itching associated with allergic conjunctivitis ( 1.2 ).
Spl product data elements
Usually a list of ingredients in a drug product.DEXTENZA dexamethasone dexamethasone dexamethasone POLYETHYLENE GLYCOL, UNSPECIFIED LYSYLLYSYLLYSINE FLUORESCEIN SODIUM PHOSPHATE, DIBASIC, ANHYDROUS SODIUM PHOSPHATE, MONOBASIC, ANHYDROUS yellow
Carcinogenesis and mutagenesis and impairment of fertility
Information about carcinogenic, mutagenic, or fertility impairment potential revealed by studies in animals. Information from human data about such potential is part of the warnings field.13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility No adequate studies in animals have been conducted to determine whether DEXTENZA has the potential for carcinogenesis. Dexamethasone was not mutagenic in the Ames/Salmonella assay, both with and without metabolic activation. Dexamethasone was genotoxic in two in vitro assays using human lymphocytes (chromosomal aberration assay and sister chromatid exchange assay) and was genotoxic in two mouse in vivo assays (micronucleus assay and sister chromatid exchange assay). Fertility studies have not been conducted in animals using DEXTENZA.
Nonclinical toxicology
Information about toxicology in non-human subjects.13 NONCLINICAL TOXICOLOGY 13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility No adequate studies in animals have been conducted to determine whether DEXTENZA has the potential for carcinogenesis. Dexamethasone was not mutagenic in the Ames/Salmonella assay, both with and without metabolic activation. Dexamethasone was genotoxic in two in vitro assays using human lymphocytes (chromosomal aberration assay and sister chromatid exchange assay) and was genotoxic in two mouse in vivo assays (micronucleus assay and sister chromatid exchange assay). Fertility studies have not been conducted in animals using DEXTENZA.
Package label principal display panel
The content of the principal display panel of the product package, usually including the product’s name, dosage forms, and other key information about the drug product.Principal Display Panel – Dextenza 1 ct Box Label NDC 70382-204-01 0.4 mg insert 1 insert Dextenza ® (dexamethasone ophthalmic insert) 0.4mg for intracanalicular use Rx only Ocular Therapeutix™ Principal Display Panel – Dextenza 1 ct Box Label
Principal Display Panel – Dextenza 10 ct Box Label NDC 70382-204-10 0.4 mg insert 10 inserts Dextenza ® (dexamethasone ophthalmic insert) 0.4mg for intracanalicular use Rx only Ocular Therapeutix™ Principal Display Panel – Dextenza 10 ct Box Label
Principal Display Panel – Dextenza Sample 1 ct Box Label NDC 70382-204-99 0.4 mg insert 1 inserts Dextenza ® (dexamethasone ophthalmic insert) 0.4mg for intracanalicular use Rx only SAMPLE Not for resale. US Patent Nos. 7,648,713 8,409,606 8,563,027 9,254,267 Ocular Therapeutix™ Principal Display Panel – Dextenza Sample 1 ct Box Label
Principal Display Panel – Dextenza Pouch Label Dextenza ® (dexamethasone ophthalmic insert) 0.4mg for intracanalicular use Ocular Therapeutix, Inc. Bedford, MA 01730 USA NDC 70382-204-88 Rx only LOT: EXP DATE: DIRECTIONS FOR USE: See enclosed package insert. Do not use if pouch has been damaged or broken. DEXTENZA is intended for single dose only. CONTENTS: One DEXTENZA insert in foam carrier. STORAGE: Refrigerate between 2 ° C - 8 ° C (36° F - 46° F). Do not freeze. Protect from light, keep in package until use. STERILE: Do not re-sterilize. PCR-780-12173 Principal Display Panel – Dextenza Pouch Label
Recent major changes
A list of the section(s) that contain substantive changes that have been approved by FDA in the product labeling. The headings and subheadings, if appropriate, affected by the change are listed together with each section’s identifying number and the month and year on which the change was incorporated in the labeling.Indications and Usage, Itching ( 1.2 ) 10/2021 Pediatric Use ( 8.4 ) 06/2024 Study in Pediatric Patients ( 14.3 ) 06/2024
| Indications and Usage, Itching ( | 10/2021 |
| Pediatric Use ( | 06/2024 |
| Study in Pediatric Patients ( | 06/2024 |
DEXTENZA: Information for patients
Information necessary for patients to use the drug safely and effectively, such as precautions concerning driving or the concomitant use of other substances that may have harmful additive effects.17 PATIENT COUNSELING INFORMATION Advise patients to consult their eye care professional, if pain, redness, or itching develops. Ocular Therapeutix™ Ocular Therapeutix, Inc. Bedford, MA 01730 USA US Patent Nos.: 8,409,606; 8,563,027; 9,254,267
Clinical studies
This field may contain references to clinical studies in place of detailed discussion in other sections of the labeling.14 CLINICAL STUDIES 14.1 Ocular Inflammation and Pain Following Ophthalmic Surgery In three randomized, multicenter, double-masked, parallel group, vehicle-controlled efficacy trials, patients received DEXTENZA or its vehicle immediately upon completion of cataract surgery (NCT02034019, NCT02089113, NCT02736175). In all three trials, DEXTENZA had a higher proportion of patients than the vehicle group who were pain free on post-operative Day 8. On post-operative Day 14, in two of the three studies, DEXTENZA had a higher proportion of patients than the vehicle group who had an absence of anterior chamber cells that was statistically significant. Results are shown in Table 1 and Table 2 . Table 1: Percentage of Patients with Absence of Anterior Chamber Cells Study 1 Study 2 Study 3 dextenza (N=164) Vehicle (N=83) Difference (95% CI) dextenza (N=161) Vehicle (N=80) Difference (95% CI) Dextenza (N=216) Vehicle (N=222) Difference (95% CI) Visit n (%) n (%) n (%) n (%) n (%) n (%) Day 14 54 (33%) 12 (14%) 18% (8%, 29%) 63 (39%) 25 (31%) 8% (-5%, 21%) 113 (52%) 69 (31%) 21 % (12%, 30%) Table 2: Percentage of Patients with Absence of Pain Study 1 Study 2 Study 3 Dextenza (N=164) Vehicle (N=83) Difference (95% CI) Dextenza (N=161) Vehicle (N=80) Difference (95% CI) Dextenza (N=216) Vehicle (N=222) Difference (95% CI) Visit n (%) n (%) n (%) n (%) n (%) n (%) Day 8 131 (80%) 36 (43%) 37% (24%, 49%) 124 (77%) 47 (59%) 18% (6%, 31%) 172 (80%) 136 (61%) 18% (10%, 27%) 14.2 Itching associated with Allergic Conjunctivitis In three randomized, multicenter, double-masked, parallel group, vehicle-controlled efficacy trials, patients received DEXTENZA or its vehicle utilizing a repeat conjunctival allergen challenge model (NCT02445326, NCT02988882, NCT04050865). In all three trials, DEXTENZA resulted in lower mean ocular itching scores compared with the vehicle group at all time points throughout the one-month duration of the study. In two of the three studies, a higher proportion of patients had statistically significant reductions in ocular itching on Day 8, at 3 minutes, 5 minutes and 7 minutes post-challenge in the DEXTENZA group than in the vehicle group. Results are shown in Table 3 . Table 3: Reduction in Ocular Itching Study 1 Study 2 Study 3 Dextenza (N=35) Vehicle (N=38) Difference (95% CI) Dextenza (N=44) Vehicle (N=42) Difference (95% CI) Dextenza (N=48) Vehicle (N=48) Difference (95% CI) Visit Time Point Least Square Means Least Square Means Least Square Means Day 8 3 min 1.9 2.7 -0.7 (-1.2, -0.3) 2.1 2.3 -0.2 (-0.7, 0.3) 1.8 2.7 -0.9 (-1.2, -0.4) 5 min 2.1 2.8 -0.7 (-1.2, -0.3) 2.1 2.3 -0.2 (-0.8, 0.3) 1.8 2.7 -1.0 (-1.4, -0.6) 7 min 1.9 2.7 -0.8 (-1.2, -0.4) 2.1 2.4 -0.3 (-0.8, 0.3) 1.7 2.7 -1.0 (-1.4, -0.6) 14.3 Study in Pediatric Patients The safety of DEXTENZA was evaluated in a single, randomized, multicenter, double-masked, active-controlled clinical study in 65 pediatric patients up to 5 years old for the treatment of postoperative pain and inflammation following ocular surgery for pediatric cataract. Patients were randomized to either DEXTENZA or prednisolone acetate ophthalmic suspension, 1%. As in the adult studies, patients were pain free, on post-operative Day 8 and had an absence of anterior chamber cells, on post-operative Day 14, in the DEXTENZA treated group. No overall differences in safety were observed between pediatric and adult patients.
| 54 (33%) | 12 (14%) | 18% (8%, 29%) | 63 (39%) | 25 (31%) | 8% (-5%, 21%) | 113 (52%) | 69 (31%) | 21 % (12%, 30%) | |||
| 131 (80%) | 36 (43%) | 37% (24%, 49%) | 124 (77%) | 47 (59%) | 18% (6%, 31%) | 172 (80%) | 136 (61%) | 18% (10%, 27%) | |||
| 3 min | 1.9 | 2.7 | -0.7 (-1.2, -0.3) | 2.1 | 2.3 | -0.2 (-0.7, 0.3) | 1.8 | 2.7 | -0.9 (-1.2, -0.4) | |||
| 5 min | 2.1 | 2.8 | -0.7 (-1.2, -0.3) | 2.1 | 2.3 | -0.2 (-0.8, 0.3) | 1.8 | 2.7 | -1.0 (-1.4, -0.6) | |||
| 7 min | 1.9 | 2.7 | -0.8 (-1.2, -0.4) | 2.1 | 2.4 | -0.3 (-0.8, 0.3) | 1.7 | 2.7 | -1.0 (-1.4, -0.6) | |||
Geriatric use
Information about any limitations on any geriatric indications, needs for specific monitoring, hazards associated with use of the drug in the geriatric population.8.5 Geriatric Use No overall differences in safety or effectiveness have been observed between elderly and younger patients.
Pediatric use
Information about any limitations on any pediatric indications, needs for specific monitoring, hazards associated with use of the drug in any subsets of the pediatric population (such as neonates, infants, children, or adolescents), differences between pediatric and adult responses to the drug, and other information related to the safe and effective pediatric use of the drug.8.4 Pediatric Use The safety and effectiveness of DEXTENZA have been established in the pediatric population from neonates to adolescents (birth to younger than 17 years). Use of DEXTENZA in this population is supported by evidence from adequate and well-controlled studies of DEXTENZA in adults with additional data from a single active-controlled safety study in pediatric patients from 0 to 5 years old [see Clinical Studies ( 14 )] . No overall differences in safety were observed between pediatric and adult patients.
Pregnancy
Information about effects the drug may have on pregnant women or on a fetus. This field may be ommitted if the drug is not absorbed systemically and the drug is not known to have a potential for indirect harm to the fetus. It may contain information about the established pregnancy category classification for the drug. (That information is nominally listed in the teratogenic_effects field, but may be listed here instead.)8.1 Pregnancy Risk Summary There are no adequate or well-controlled studies with DEXTENZA in pregnant women to inform a drug-associated risk for major birth defects and miscarriage. In animal reproduction studies, administration of topical ocular dexamethasone to pregnant mice and rabbits during organogenesis produced embryofetal lethality, cleft palate and multiple visceral malformations [see Animal Data ] . Data Animal Data Topical ocular administration of 0.15% dexamethasone (0.75 mg/kg/day) on gestational days 10 to 13 produced embryofetal lethality and a high incidence of cleft palate in a mouse study. A daily dose of 0.75 mg/kg/day in the mouse is approximately 5 times the entire dose of dexamethasone in the DEXTENZA product, on a mg/m 2 basis. In a rabbit study, topical ocular administration of 0.1% dexamethasone throughout organogenesis (0.36 mg /day, on gestational day 6 followed by 0.24 mg/day on gestational days 7-18) produced intestinal anomalies, intestinal aplasia, gastroschisis and hypoplastic kidneys. A daily dose of 0.24 mg/day is approximately 6 times the entire dose of dexamethasone in the DEXTENZA product, on a mg/m 2 basis.
Use in specific populations
Information about use of the drug by patients in specific populations, including pregnant women and nursing mothers, pediatric patients, and geriatric patients.8 USE IN SPECIFIC POPULATIONS 8.1 Pregnancy Risk Summary There are no adequate or well-controlled studies with DEXTENZA in pregnant women to inform a drug-associated risk for major birth defects and miscarriage. In animal reproduction studies, administration of topical ocular dexamethasone to pregnant mice and rabbits during organogenesis produced embryofetal lethality, cleft palate and multiple visceral malformations [see Animal Data ] . Data Animal Data Topical ocular administration of 0.15% dexamethasone (0.75 mg/kg/day) on gestational days 10 to 13 produced embryofetal lethality and a high incidence of cleft palate in a mouse study. A daily dose of 0.75 mg/kg/day in the mouse is approximately 5 times the entire dose of dexamethasone in the DEXTENZA product, on a mg/m 2 basis. In a rabbit study, topical ocular administration of 0.1% dexamethasone throughout organogenesis (0.36 mg /day, on gestational day 6 followed by 0.24 mg/day on gestational days 7-18) produced intestinal anomalies, intestinal aplasia, gastroschisis and hypoplastic kidneys. A daily dose of 0.24 mg/day is approximately 6 times the entire dose of dexamethasone in the DEXTENZA product, on a mg/m 2 basis. 8.2 Lactation Systemically administered corticosteroids appear in human milk and could suppress growth and interfere with endogenous corticosteroid production; however the systemic concentration of dexamethasone following administration of DEXTENZA is low [see Clinical Pharmacology ( 12.3 )] . There is no information regarding the presence of DEXTENZA in human milk, the effects of the drug on the breastfed infant or the effects of the drug on milk production to inform risk of DEXTENZA to an infant during lactation. The developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for DEXTENZA and any potential adverse effects on the breastfed child from DEXTENZA. 8.4 Pediatric Use The safety and effectiveness of DEXTENZA have been established in the pediatric population from neonates to adolescents (birth to younger than 17 years). Use of DEXTENZA in this population is supported by evidence from adequate and well-controlled studies of DEXTENZA in adults with additional data from a single active-controlled safety study in pediatric patients from 0 to 5 years old [see Clinical Studies ( 14 )] . No overall differences in safety were observed between pediatric and adult patients. 8.5 Geriatric Use No overall differences in safety or effectiveness have been observed between elderly and younger patients.
How supplied
Information about the available dosage forms to which the labeling applies, and for which the manufacturer or distributor is responsible. This field ordinarily includes the strength of the dosage form (in metric units), the units in which the dosage form is available for prescribing, appropriate information to facilitate identification of the dosage forms (such as shape, color, coating, scoring, and National Drug Code), and special handling and storage condition information.16 HOW SUPPLIED/STORAGE AND HANDLING DEXTENZA is supplied sterile in a foam carrier within a foil laminate pouch containing: NDC 70382-204-10 Carton containing 10 pouches (10 inserts) NDC 70382-204-01 Carton containing 1 pouch (1 insert) Do not use if pouch has been damaged or broken. DEXTENZA is intended for single dose only. Storage: Store refrigerated, between 2°C and 8°C (36°F and 46°F). Do not freeze. Protect from light, keep in package until use.
| NDC 70382-204-10 | Carton containing 10 pouches (10 inserts) |
| NDC 70382-204-01 | Carton containing 1 pouch (1 insert) |
Storage and handling
Information about safe storage and handling of the drug product.Storage: Store refrigerated, between 2°C and 8°C (36°F and 46°F). Do not freeze. Protect from light, keep in package until use.
Disclaimer: Do not rely on openFDA or Phanrmacy Near Me to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Source: OpenFDA, Healthporta Drugs API