IPRATROPIUM BROMIDE spray

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

IPRATROPIUM BROMIDE (UNII: J697UZ2A9J) (IPRATROPIUM - UNII:GR88G0I6UL)

Available from:

Bryant Ranch Prepack

Administration route:

NASAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Ipratropium bromide nasal solution 0.06% is indicated for the symptomatic relief of rhinorrhea associated with the common cold or seasonal allergic rhinitis for adults and children age 5 years and older. Ipratropium bromide 0.06% does not relieve nasal congestion or sneezing associated with the common cold or seasonal allergic rhinitis. The safety and effectiveness of the use of ipratropium bromide 0.06% beyond four days in patients with the common cold or beyond three weeks in patients with seasonal allergic rhinitis has not been established. Ipratropium bromide nasal solution 0.06% is contraindicated in patients with a history of hypersensitivity to atropine or its derivatives, or to any of the other ingredients. Ipratropium Bromide Nasal Solution 0.06% Nasal Spray, 42 mcg/spray Rx Only Read complete instructions carefully before using. In order to ensure proper dosing, do not attempt to change the size of the spray opening. Ipratropium bromide nasal solution 0.06% is indicated for the symptomatic relief of rhinorrhea (runny nose) associated with the common cold or seasonal allergic rhinitis for adults and children age 5 years and older. Ipratropium bromide nasal solution 0.06% does not relieve nasal congestion or sneezing, associated with the common cold or seasonal allergic rhinitis. Do not use ipratropium bromide nasal solution 0.06 % for longer than four days for a common cold or three weeks for seasonal allergic rhinitis unless instructed by your physician. Read complete instructions carefully and use only as directed. To Use: Figure 1 Figure 1 Figure 2 Figure 2 Figure 3 Figure 3 To Clean: If the nasal tip becomes clogged, remove the clear plastic dust cap and safety clip. Hold the nasal tip under running, warm tap water (Figure 4) for about a minute. Dry the nasal tip, reprime the nasal spray pump (step 2 above), and replace the plastic dust cap and safety clip. Figure 4 Figure 4 Caution: Ipratropium bromide nasal solution 0.06% is intended to relieve your rhinorrhea (runny nose) with regular use. It is therefore important that you use ipratropium bromide nasal solution 0.06% as prescribed by your physician. For most patients, some improvement in runny nose is usually apparent following the first dose of treatment with ipratropium bromide nasal solution 0.06%. Do not use ipratropium bromide nasal solution 0.06% for longer than four days for your cold or three weeks for seasonal allergic rhinitis unless instructed by your physician. Do not spray ipratropium bromide nasal solution 0.06% in your eyes. Should this occur, immediately flush your eye with cool tap water for several minutes. If you accidentally spray ipratropium bromide nasal solution 0.06% in your eyes, you may experience a temporary blurring of vision, visual halos or colored images in association with red eyes from conjunctival and corneal congestion, development or worsening of narrow-angle glaucoma, pupil dilation, or acute eye pain/discomfort, and increased sensitivity to light, which may last a few hours. Should eye pain or blurred vision occur, contact your doctor. Should you experience excessive nasal dryness or episodes of nasal bleeding, contact your doctor. If you have glaucoma or difficulty urinating due to an enlargement of the prostate, be sure to tell your physician prior to using ipratropium bromide nasal solution 0.06%. If you are pregnant or breast feeding your baby, be sure to tell your physician prior to using ipratropium bromide nasal solution 0.06%. Storage Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.] Avoid freezing. Keep out of reach of children. Address medical inquiries to Hikma Pharmaceuticals USA Inc. at 1-800-962-8364. Distributed by: Hikma Pharmaceuticals USA Inc. Berkeley Heights, NJ 07922 C50000618/01 Revised July 2022

Product summary:

Ipratropium Bromide Nasal Solution 0.06% is supplied as a clear, colorless solution in a white high density polyethylene (HDPE) bottle fitted with a white and clear metered nasal spray pump, a green safety clip to prevent accidental discharge of the spray, and a clear plastic dust cap. It contains 16.6 g of product formulation, 165 sprays, each delivering 42 mcg (70 mcL) of ipratropium per spray, or 10 days of therapy at the maximum recommended dose (two sprays per nostril four times a day). Ipratopium Bromide Nasal Solution, 0.06% Nasal Spray, 42 mcg/spray NDC 72162-2144-2 : Bottle of 15 mL (165 metered sprays) Storage Store at 20° to 25°C (68° to 77°F).[See USP Controlled Room Temperature.] Avoid freezing. Keep out of reach of children. Do not spray in the eyes. Repackaged/Relabeled by: Bryant Ranch Prepack, Inc. Burbank, CA 91504

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

IPRATROPIUM BROMIDE- IPRATROPIUM BROMIDE SPRAY
BRYANT RANCH PREPACK
----------
IPRATROPRIUM BROMIDE NASAL SOLUTION, 0.06%
NASAL SPRAY, 42 MCG/SPRAY
_ATTENTION PHARMACISTS: DETACH “PATIENT’S INSTRUCTIONS FOR USE”
FROM_
_PACKAGE INSERT AND DISPENSE WITH PRODUCT._
RX ONLY
DESCRIPTION
The active ingredient in Ipratropium Bromide Nasal Solution is
ipratropium bromide (as
the monohydrate). It is an anticholinergic agent chemically described
as 8-azoniabicyclo
[3.2.1] octane,
3-(3-hydroxy-1-oxo-2-phenylpropoxy)-8-methyl-8-(1-methylethyl)-,
bromide monohydrate (3-endo, 8-syn)-: a synthetic quaternary ammonium
compound,
chemically related to atropine. The structural formula is:
IPRATROPIUM BROMIDE C
H
BRNO • H2O MOL. WT. 430.4
ipratropium bromide C
H
BrNO • H2O Mol. Wt. 430.4
Ipratropium bromide is a white to off-white crystalline substance,
freely soluble in water
and methanol, sparingly soluble in ethanol, and insoluble in non-polar
media. In aqueous
solution, it exists in an ionized state as a quaternary ammonium
compound.
Ipratropium Bromide Nasal Solution, 0.06% is a metered-dose, manual
pump spray unit
which delivers 42 mcg (70 mcL) ipratropium bromide per spray on an
anhydrous basis
in an isotonic, aqueous solution with pH adjusted to 4.7 with
hydrochloric acid and/or
sodium hydroxide (if needed). It also contains benzalkonium chloride,
edetate disodium,
20 30
3
20
30
3
purified water and sodium chloride. Each bottle contains 165 metered
sprays.
CLINICAL PHARMACOLOGY
MECHANISM OF ACTION
Ipratropium bromide is an anticholinergic (para-sympatholytic) agent
which, based on
animal studies, appears to inhibit vagally-mediated reflexes by
antagonizing the action of
acetylcholine, the transmitter agent released at the neuromuscular
junctions in the lung.
In humans, ipratropium bromide has anti-secretory properties and, when
applied locally,
inhibits secretions from the serous and seromucous glands lining the
nasal mucosa.
Ipratropium bromide is a quaternary amine that minimally crosses the
nasal and
gastrointest