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NDC 32909-0116-00 Varibar Nectar 400 mg/mL Details
Varibar Nectar 400 mg/mL
Varibar Nectar is a ORAL SUSPENSION in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by E-Z-EM Canada Inc. The primary component is BARIUM SULFATE.
Product Information
| NDC | 32909-0116 |
|---|---|
| Product ID | 32909-116_812e1e37-1e0f-831b-6a7e-60fdc7c43e82 |
| Associated GPIs | 94401010101834 |
| GCN Sequence Number | 059660 |
| GCN Sequence Number Description | barium sulfate ORAL SUSP 40 % (W/V) ORAL |
| HIC3 | D0U |
| HIC3 Description | GASTROINTESTINAL RADIOPAQUE DIAGNOSTICS |
| GCN | 25405 |
| HICL Sequence Number | 001119 |
| HICL Sequence Number Description | BARIUM SULFATE |
| Brand/Generic | Brand |
| Proprietary Name | Varibar Nectar |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | barium sulfate |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Dosage Form | SUSPENSION |
| Route | ORAL |
| Active Ingredient Strength | 400 |
| Active Ingredient Units | mg/mL |
| Substance Name | BARIUM SULFATE |
| Labeler Name | E-Z-EM Canada Inc |
| Pharmaceutical Class | Radiographic Contrast Agent [EPC], X-Ray Contrast Activity [MoA] |
| DEA Schedule | n/a |
| Marketing Category | NDA |
| Application Number | NDA208143 |
| Listing Certified Through | 2024-12-31 |
Package
Package Images
NDC 32909-0116-00 (32909011600)
| NDC Package Code | 32909-116-00 |
|---|---|
| Billing NDC | 32909011600 |
| Package | 240 mL in 1 BOTTLE, PLASTIC (32909-116-00) |
| Marketing Start Date | 2020-11-01 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |
Standard Product Labeling (SPL)/Prescribing Information SPL 5e7045f7-b771-d8af-ce30-be95b2597c10 Details
HIGHLIGHTS OF PRESCRIBING INFORMATION
VARIBAR NECTAR (barium sulfate) oral suspension
Initial U.S. Approval: 2016
INDICATIONS AND USAGE
VARIBAR NECTAR is a radiographic contrast agent indicated for use in modified barium swallow examinations to evaluate the oral and pharyngeal function and morphology in adult and pediatric patients. (1)
DOSAGE AND ADMINISTRATION
- For oral use only – administered by syringe, spoon, or cup. The recommended dose is:
- Adults: 5 mL
- Pediatric patients 6 months and older: 1-3 mL
- Pediatric patients younger than 6 months of age: 0.5-1 mL
- Maximum cumulative dose: 30 mL
- During a single modified barium swallow examination, multiple doses of VARIBAR NECTAR may be administered. (2)
DOSAGE FORMS AND STRENGTHS
- Oral suspension — 40% (w/v) in a 240 mL multiple-dose HDPE plastic bottle for oral administration (3)
CONTRAINDICATIONS
WARNINGS AND PRECAUTIONS
- Hypersensitivity reactions: Emergency equipment and trained personnel should be immediately available (5.1)
- Intra-abdominal barium leakage: May occur in conditions such as GI fistula, ulcer, inflammatory bowel disease, appendicitis or diverticulitis, severe stenosis or obstructing lesions of the GI tract (5.2)
- Delayed GI transit and obstruction: Patients should maintain adequate hydration in days following a barium sulfate procedure to avoid obstruction or impaction (5.3)
- Aspiration pneumonitis: Aspiration may occur during the modified barium swallow examination. Monitor the patient for aspiration (5.4)
ADVERSE REACTIONS
Common adverse reactions include nausea, vomiting, diarrhea and abdominal cramping (6)
To report SUSPECTED ADVERSE REACTIONS, contact Bracco Diagnostics Inc at 1-800-257-5181 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch
See 17 for PATIENT COUNSELING INFORMATION.
Revised: 2/2018
Table Of Contents
FULL PRESCRIBING INFORMATION: CONTENTS*
1 INDICATIONS AND USAGE
2 DOSAGE AND ADMINISTRATION
2.1 Recommended Dosing
2.2 Important Administration Instructions
3 DOSAGE FORMS AND STRENGTHS
4 CONTRAINDICATIONS
5 WARNINGS AND PRECAUTIONS
5.1 Hypersensitivity Reactions
5.2 Intra-abdominal Barium Leakage
5.3 Delayed Gastrointestinal Transit and Obstruction
5.4 Aspiration Pneumonitis
5.5 Systemic Embolization
6 ADVERSE REACTIONS
8 USE IN SPECIFIC POPULATIONS
8.1 Pregnancy
8.2 Lactation
8.4 Pediatric Use
8.5 Geriatric Use
11 DESCRIPTION
12 CLINICAL PHARMACOLOGY
12.1 Mechanism of Action
12.2 Pharmacodynamics
12.3 Pharmacokinetics
13 NONCLINICAL TOXICOLOGY
13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility
16 HOW SUPPLIED/STORAGE AND HANDLING
17 PATIENT COUNSELING INFORMATION
- *
- Sections or subsections omitted from the full prescribing information are not listed.
1 INDICATIONS AND USAGE
2 DOSAGE AND ADMINISTRATION
2.1 Recommended Dosing
- The recommended dose of VARIBAR NECTAR administered orally
by syringe, spoon, or cup:
- Adults 5 mL
- Pediatric patients 6 months and older 1-3 mL
- Pediatric patients younger than 6 months of age 0.5-1
mL
(This amount may be administered by an oral syringe or, alternatively, an infant bottle)
- During a single modified barium swallow examination, multiple doses of VARIBAR NECTAR may be administered as appropriate to assess the patient during multiple swallows and different radiographic views.
- The maximum cumulative dose is 30 mL.
- Once opened, write the discard after date on the immediate container label. Discard any unused product after 21 days.
3 DOSAGE FORMS AND STRENGTHS
4 CONTRAINDICATIONS
VARIBAR NECTAR is contraindicated in patients with:
- known or suspected perforation of the GI tract
- known obstruction of the GI tract
- high risk of GI perforation such as those with a recent prior GI perforation, acute GI hemorrhage or ischemia, toxic megacolon, severe ileus, post GI surgery or biopsy, acute GI injury or burn, or recent radiotherapy to the pelvis
- high risk for aspiration such as those with known or suspected tracheo-esophageal fistula or obtundation
- known severe hypersensitivity to barium sulfate or any of the excipients of VARIBAR NECTAR
5 WARNINGS AND PRECAUTIONS
5.1 Hypersensitivity Reactions
Barium sulfate preparations contain a number of excipients, including natural and artificial flavors and may induce serious hypersensitivity reactions. The manifestations include hypotension, bronchospasm and other respiratory impairments, dermal reactions including rashes, urticaria and itching. A history of bronchial asthma, atopy or a previous reaction to a contrast agent may increase the risk for hypersensitivity reactions. Emergency equipment and trained personnel should be immediately available for treatment of a hypersensitivity reaction.
5.2 Intra-abdominal Barium Leakage
The use of VARIBAR NECTAR is contraindicated in patients at high risk of perforation of the GI tract [see Contraindications (4)]. Administration of VARIBAR NECTAR may result in leakage of barium at any level of the GI tract in the presence of conditions such as carcinomas, GI fistula, inflammatory bowel disease, gastric or duodenal ulcer, appendicitis or diverticulitis, and in patients with a severe stenosis at any level of the GI tract, especially if it is distal to the stomach. The barium leakage has been associated with peritonitis and granuloma formation.
5.3 Delayed Gastrointestinal Transit and Obstruction
Orally administered barium sulfate may accumulate proximal to a constricting lesion of the colon, causing obstruction or impaction with development of baroliths (inspissated barium associated with feces) and may lead to abdominal pain, appendicitis, bowel obstruction, or rarely perforation. Patients with the following conditions are at higher risk for developing obstruction or baroliths: severe stenosis at any level of the GI tract, impaired GI motility, electrolyte imbalance, dehydration, on a low residue diet, taking medications that delay GI motility, constipation, pediatric patients with cystic fibrosis or Hirschsprung disease, and the elderly [see Use in Specific Populations (8.4, 8.5)]. To reduce the risk of delayed GI transit and obstruction, patients should maintain adequate hydration following a barium sulfate procedure.
5.4 Aspiration Pneumonitis
The use of VARIBAR NECTAR is contraindicated in patients with tracheo-esophageal fistula [see Contraindications (4)]. Oral administration of barium is associated with aspiration pneumonitis, especially in patients with a history of food aspiration or with compromised swallowing mechanism. Vomiting following oral administration of barium sulfate may lead to aspiration pneumonitis.
In patients at risk for aspiration, begin the procedure with a small ingested volume of VARIBAR NECTAR. Aspiration of small volumes of barium sulfate may occur during the modified barium swallow procedure in some patients. Monitor the patient closely for aspiration, discontinue administration if aspiration is suspected and monitor for development of aspiration pneumonitis.
5.5 Systemic Embolization
Barium sulfate products may occasionally intravasate into the venous drainage of the large bowel and enter the circulation as a "barium embolus" leading to potentially fatal complications which include systemic and pulmonary embolism, disseminated intravascular coagulation, septicemia and prolonged severe hypotension. Although this complication is exceedingly uncommon after oral administration of barium sulfate products, monitor patients for potential intravasation when administering barium sulfate.
6 ADVERSE REACTIONS
The following adverse reactions have been identified from spontaneous reporting or clinical studies of barium sulfate administered orally. Because the reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or to establish a causal relationship to drug exposure:
- Nausea, vomiting, diarrhea and abdominal cramping
- Serious adverse reactions and fatalities include aspiration pneumonitis, barium sulfate impaction, intestinal perforation with consequent peritonitis and granuloma formation, vasovagal and syncopal episodes
8 USE IN SPECIFIC POPULATIONS
8.1 Pregnancy
VARIBAR NECTAR is not absorbed systemically following oral administration, and maternal use is not expected to result in fetal exposure to the drug [see Clinical Pharmacology (12.3)].
8.2 Lactation
VARIBAR NECTAR is not absorbed systemically by the mother following oral administration, and breastfeeding is not expected to result in exposure of the infant to VARIBAR NECTAR [see Clinical Pharmacology (12.3)].
8.4 Pediatric Use
The efficacy of VARIBAR NECTAR in pediatric patients from birth to less than 17 years of age is based on successful opacification of the oropharynx during modified barium swallow examinations [see Clinical Pharmacology (12.1)]. Safety and dosing recommendations in pediatric patients are based on clinical experience [see Dosage and Administration (2.1)].
VARIBAR NECTAR is contraindicated in pediatric patients with tracheo-esophageal fistula [see Contraindications (4)]. Pediatric patients with a history of asthma or food allergies may be at increased risk for development of hypersensitivity reactions [see Warnings and Precautions (5.1)]. Patients with cystic fibrosis or Hirschsprung disease should be monitored for small bowel obstruction after use [see Warnings and Precautions (5.3)]
8.5 Geriatric Use
Clinical studies of VARIBAR NECTAR do not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. Other reported clinical experience has not identified 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, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy.
11 DESCRIPTION
VARIBAR NECTAR (barium sulfate) is a radiographic contrast agent for oral administration that is supplied as a 40% w/v, smooth, off- white to lightly colored free-flowing suspension with an apple aroma. The active ingredient is designated chemically as BaSO4 which has a density of 4.5 g/cm3, a molecular weight of 233.4 g/mol, and the following chemical structure:
VARIBAR NECTAR has a viscosity of 300 cPs and contains the following excipients: carboxymethylcellulose sodium, citric acid, glycerin, maltodextrin, natural and artificial apple flavor, polysorbate 80, potassium sorbate, purified water, saccharin sodium, simethicone emulsion, sodium benzoate, sodium citrate, xanthan gum, and xylitol.
12 CLINICAL PHARMACOLOGY
13 NONCLINICAL TOXICOLOGY
16 HOW SUPPLIED/STORAGE AND HANDLING
VARIBAR NECTAR is supplied in a multiple-dose HDPE bottle containing 240 mL of barium sulfate (40% w/v).
Provided as: 12 x 240 mL bottles (NDC 32909-116-00)
Store at USP controlled room temperature 20 to 25°C (68 to 77° F). Protect from freezing.
Once opened, VARIBAR NECTAR may be used for up to 21 days when stored at USP controlled room temperature, 20 to 25°C (68 to 77° F).
17 PATIENT COUNSELING INFORMATION
After administration, advise patients to:
- Maintain adequate hydration [see Dosage and Administration (2.2) and Warnings and Precautions (5.3)].
- Seek medical attention for worsening of constipation or slow gastrointestinal passage [see Warnings and Precautions (5.3)].
- Seek medical attention for any delayed onset of hypersensitivity: rash, urticaria, or respiratory difficulty [see Warnings and Precautions (5.1)].
Manufactured
for
Bracco Diagnostics Inc.
Monroe Township,
NJ 08831
by EZEM Canada Inc
Anjou (Quebec) Canada
H1J 2Z4
PRINCIPAL DISPLAY PANEL
INGREDIENTS AND APPEARANCE
| VARIBAR NECTAR
barium sulfate suspension |
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| VARIBAR NECTAR
barium sulfate suspension |
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| Labeler - E-Z-EM Canada Inc (204211163) |
| Registrant - E-Z-EM, INC. (002041226) |
| Establishment | |||
| Name | Address | ID/FEI | Business Operations |
|---|---|---|---|
| E-Z-EM Canada Inc | 204211163 | ANALYSIS(32909-115, 32909-116) , PACK(32909-115, 32909-116) , MANUFACTURE(32909-116, 32909-115) , LABEL(32909-115, 32909-116) | |