IPRATROPIUM BROMIDE solution

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Ritedose Pharmaceuticals, LLC

INN (International Name):

Ipratropium Bromide

Composition:

IPRATROPIUM BROMIDE ANHYDROUS 0.5 mg in 2.5 mL

Administration route:

RESPIRATORY (INHALATION)

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Ipratropium Bromide Inhalation Solution administered either alone or with other bronchodilators, especially beta adrenergics, is indicated as a bronchodilator for maintenance treatment of bronchospasm associated with chronic obstructive pulmonary disease, including chronic bronchitis and emphysema. Ipratropium bromide is contraindicated in known or suspected cases of hypersensitivity to ipratropium bromide, or to atropine and its derivatives. Ipratropium Bromide Inhalation Solution 0.02% Read complete instructions carefully before using. - Twist open the top of one unit dose vial and squeeze the contents into the nebulizer reservoir. (Figure 1). - Connect the nebulizer reservoir to the mouthpiece or face mask (Figure 2). - Connect the nebulizer to the compressor. - Sit in a comfortable, upright position; place the mouthpiece in your mouth (Figure 3) or put on the face mask and turn on the compressor. If a face mask is used, care should be taken to avoid leakage around the mask as temporary blurring of vision, pupil enlargement, precipitation or worsening of narrow angle glaucoma, or eye pain may occur if the solution comes into direct contact with the eyes. - Breathe as calmly, deeply, and evenly as possible until no more mist is formed in the nebulizer chamber (about 5 to 15 minutes). At this point, the treatment is finished. - Clean the nebulizer (see manufacturer's instructions). Note: Use only as directed by your physician. More frequent administration or higher doses are not recommended. Ipratropium Bromide Inhalation Solution can be mixed in the nebulizer with albuterol or metaproterenol if used within one hour but not with other drugs. Drug stability and safety of Ipratropium Bromide Inhalation Solution when mixed with other drugs in the nebulizer have not been established. Store between 59°F (15°C) and 86°F (30°). Protect from light. Store unused vials in the foil pouch. ADDITIONAL INSTRUCTIONS: ____________________________________ ____________________________________ ____________________________________ ____________________________________ ____________________________________ ____________________________________ ____________________________________

Product summary:

Ipratropium Bromide Inhalation Solution Unit Dose Vial is supplied as a 0.02% clear, colorless solution containing 2.5 mL. NDC 76204-100-25, 25 vials per carton / 25 vials per foil pouch NDC 76204-100-30, 30 vials per carton / 30 vials per foil pouch NDC 76204-100-01, 30 vials per carton / 1 vial per foil pouch NDC 76204-100-60, 60 vials per carton / 30 vials per foil pouch Each vial is made from a low density polyethylene (LDPE) resin. Vials are supplied in a foil pouch. Store between 59°F (15°C) and 86°F (30°C). Protect from light. Store unused vials in the foil pouch.

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

IPRATROPIUM BROMIDE- IPRATROPIUM BROMIDE SOLUTION
RITEDOSE PHARMACEUTICALS, LLC
----------
IPRATROPIUM BROMIDE INHALATION SOLUTION 0.02%
PRESCRIBING INFORMATION
RX ONLY
DESCRIPTION
The active ingredient, ipratropium bromide monohydrate, USP, is an
anticholinergic
bronchodilator chemically described as 8-azoniabicyclo [3.2.1]-
octane, 3-(3-hydroxy-1-
oxo-2-phenylpropoxy)-8-methyl-8-(1-methylethyl)-, bromide, monohydrate
(endo, syn)-,
(±)-; a synthetic quaternary ammonium compound, chemically related to
atropine.
Ipratropium Bromide Monohydrate C
H
BrNO
•H
O Mol.Wt. 430.4
Ipratropium bromide is a white crystalline substance, freely soluble
in water and lower
alcohols. It is a quaternary ammonium compound and thus exists in an
ionized state in
aqueous solutions. It is relatively insoluble in non-polar media.
Ipratropium Bromide Inhalation Solution is administered by oral
inhalation with the aid of
a nebulizer. It contains ipratropium bromide, USP 0.02% (anhydrous
basis) in a sterile,
preservative-free, isotonic saline solution, pH-adjusted to 3.4 (3 to
4) with hydrochloric
acid.
CLINICAL PHARMACOLOGY
Ipratropium bromide is an anticholinergic (parasympatholytic) agent
that, based on
animal studies, appears to inhibit vagally mediated reflexes by
antagonizing the action of
acetylcholine, the transmitter agent released from the vagus nerve.
Anticholinergics prevent the increases in intracellular concentration
of cyclic guanosine
monophosphate (cyclic GMP) that are caused by interaction of
acetylcholine with the
muscarinic receptor on bronchial smooth muscle.
The bronchodilation following inhalation of ipratropium bromide is
primarily a local, site-
specific effect, not a systemic one. Much of an administered dose is
swallowed but not
absorbed, as shown by fecal excretion studies. Following nebulization
of a 2 mg dose, a
mean 7% of the dose was absorbed into the systemic circulation either
from the surface
of the lung or from the gastrointestinal tract. The half-life of
elimination is about 1.6
hours after intravenou