NDC 16590-883 Brimonidine Tartrate

NDC Product Code 16590-883

NDC CODE: 16590-883

Proprietary Name: Brimonidine Tartrate What is the Proprietary Name?
The proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.

Drug Use Information

Drug Use Information
The drug use information is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate. This information is not individual medical advice and does not substitute for the advice of a health care professional. Always ask a health care professional for complete information about this product and your specific health needs.

  • This medication is used to treat open-angle glaucoma or high fluid pressure in the eye. Lowering high fluid pressure in the eye reduces the risk of vision loss, nerve damage, or blindness. This medication lowers pressure by allowing better fluid drainage from within the eye and also by reducing the amount of fluid formed in the eye. It is known as an alpha agonist. This drug is not recommended for use in children less than 2 years of age due to an increased risk of serious side effects such as very slowed breathing. Ask the doctor or pharmacist for details.

NDC Code Structure

  • 16590 - Stat Rx Usa Llc

NDC 16590-883-10

Package Description: 10 mL in 1 BOTTLE, DROPPER

This product is EXCLUDED from the official NDC directory because the listing data was inactivated by the FDA.

NDC Product Information

Information for Patients

Brimonidine Ophthalmic

Brimonidine Ophthalmic is pronounced as (bri moe' ni deen)

Why is brimonidine ophthalmic medication prescribed?
Ophthalmic brimonidine is used to lower pressure in the eyes in patients who have glaucoma (high pressure in the eyes that may damage nerves and cause vision loss) and oc...
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Brimonidine Tartrate Product Labeling Information

The product labeling information includes all published material associated to a drug. Product labeling documents include information like generic names, active ingredients, ingredient strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.

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Description:

Brimonidine Tartrate Ophthalmic Solution 0.2% is a relatively selective alpha-2
adrenergic agonist for ophthalmic use. In solution, brimonidine tartrate
ophthalmic solution 0.2% has a clear, greenish-yellow color. It has an
osmolality of 280-330 mOsml/kg and a pH of 5.6-6.6 The structural formula is:C11H10BrN5 • C4H6O6Mol. Wt. 442.24 (as the tartrate salt)Chemical Name: 5-bromo-6-(2-imidazolidinylideneamino)
quinoxaline L-tartrate.CAS Number 59803-98-4Each mL Contains:ACTIVE: Brimonidine tartrate: 0.2% (2 mg/mL).INACTIVES: Citric Acid, Polyvinyl Alcohol, Sodium Chloride, Sodium Citrate,
Purified Water. Hydrochloric Acid and/or Sodium Hydroxide may be added to adjust
pH.PRESERVATIVE ADDED: Benzalkonium Chloride (0.05 mg).

Clinical Pharmacology:

Mechanism of Action:Brimonidine tartrate ophthalmic solution 0.2% is an alpha
adrenergic receptor agonist. It has a peak ocular hypotensive effect occurring
at two hours post-dosing. Fluorophotometric studies in animals and humans
suggest that brimonidine tartrate has a dual mechanism of action by reducing
aqueous humor production and increasing uveoscleral outflow.Pharmacokinetics:After ocular administration of a 0.2% solution, plasma
concentrations peaked within 1 to 4 hours and declined with a systemic half-life
of approximately 3 hours. In humans, systemic metabolism of brimonidine is
extensive. It is metabolized primarily by the liver. Urinary excretion is the
major route of elimination of the drug and its metabolites. Approximately 87% of
an orally administered radioactive dose was eliminated within 120 hours, with
74% found in the urine.Clinical Evaluations:Elevated IOP presents a major risk factor in glaucomatous field
loss. The higher the level of lOP, the greater the likelihood of optic nerve
damage and visual field loss. Brimonidine tartrate has the action of lowering
intraocular pressure with minimal effect on cardiovascular and pulmonary
parameters.In comparative clinical studies with timolol 0.5%, lasting up to one year,
the lOP lowering effect of brimonidine tartrate ophthalmic solution 0.2% was
approximately 4-6 mmHg compared with approximately 6 mmHg for timolol. In these
studies, both patient groups were dosed BID; however, due to the duration of
action of brimonidine tartrate ophthalmic solution 0.2%, it is recommended that
brimonidine tartrate ophthalmic solution 0.2% be dosed TID. Eight percent of
subjects were discontinued from studies due to inadequately controlled
intraocular pressure, which in 30% of these patients occurred during the first
month of therapy. Approximately 20% were discontinued due to adverse
experiences.

Indications And Usage:

Brimonidine tartrate ophthalmic solution 0.2% is indicated for lowering
intraocular pressure in patients with open-angle glaucoma or ocular
hypertension. The lOP lowering efficacy of brimonidine tartrate ophthalmic
solution 0.2% diminishes over time in some patients. This loss of effect appears
with a variable time of onset in each patient and should be closely monitored.

Contraindications:

Brimonidine tartrate ophthalmic solution 0.2% is contraindicated in patients
with hypersensitivity to brimonidine tartrate or any component of this
medication. It is also contraindicated in patients receiving monoamine oxidase
(MAO) inhibitor therapy.

General:

Although brimonidine tartrate ophthalmic solution 0.2% had
minimal effect on blood pressure of patients in clinical studies, caution should
be exercised in treating patients with severe cardiovascular disease.Brimonidine tartrate ophthalmic solution 0.2% has not been studied in
patients with hepatic or renal impairment; caution should be used in treating
such patients.Brimonidine tartrate ophthalmic solution 0.2% should be used with caution in
patients with depression, cerebral or coronary insufficiency, Raynaud’s
phenomenon, orthostatic hypotension or thromboangiitis obliterans.During the studies there was a loss of effect in some patients. The
IOP-lowering efficacy observed with brimonidine tartrate ophthalmic solution
0.2% during the first month of therapy may not always reflect the long-term
level of IOP reduction. Patients prescribed IOP-lowering medication should be
routinely monitored for IOP.

Information For Patients:

The preservative in brimonidine tartrate ophthalmic solution
0.2%, benzalkonium chloride, may be absorbed by soft contact lenses. Patients
wearing soft contact lenses should be instructed to wait at least 15 minutes
after instilling brimonidine tartrate ophthalmic solution 0.2% to insert soft
contact lenses.As with other drugs in this class, brimonidine tartrate ophthalmic solution
0.2% may cause fatigue and/or drowsiness in some patients. Patients who engage
in hazardous activities should be cautioned of the potential for a decrease in
mental alertness.Drug Interactions:Although specific drug interaction studies have not been
conducted with brimonidine tartrate ophthalmic solution 0.2%, the possibility of
an additive or potentiating effect with CNS depressants (alcohol, barbiturates,
opiates, sedatives, or anesthetics) should be considered. Alpha-agonists, as a
class, may reduce pulse and blood pressure. Caution in using concomitant drugs
such as beta-blockers (ophthalmic and systemic), antihypertensives and/or
cardiac glycosides is advised.Tricyclic antidepressants have been reported to blunt the hypotensive effect
of systemic clonidine. It is not known whether the concurrent use of these
agents with brimonidine tartrate ophthalmic solution 0.2% in humans can lead to
resulting interference with the IOP lowering effect. No data on the level of
circulating catecholamines after brimonidine tartrate ophthalmic solution 0.2%
are available. Caution, however, is advised in patients taking tricyclic
antidepressants which can affect the metabolism and uptake of circulating
amines.Carcinogenesis, mutagenesis, impairment of
fertility:No compound-related carcinogenic effects were observed in either
mice or rats following a 21-month and 24-month study, respectively. In these
studies, dietary administration of brimonidine tartrate at doses up to 2.5
mg/kg/day in mice and 1.0 mg/kg/day in rats achieved ~77 and 118 times,
respectively, the plasma drug concentration estimated in humans treated with one
drop brimonidine tartrate ophthalmic solution 0.2% into both eyes 3 times per
day.Brimonidine tartrate was not mutagenic or cytogenic in a series of in vitro and in vivo studies
including the Ames test, chromosomal aberation assay in Chinese Hamster Ovary
(CHO) cells, a host-mediated assay and cytogenic studies in mice, and dominant
lethal assay.Reproductive studies performed in rats with oral doses of 0.66 mg base/kg
revealed no evidence of harm to the fetus due to brimonidine tartrate ophthalmic
solution 0.2%.Pregnancy:Teratogenic Effects: Pregnancy Category
B.Reproductive studies performed in rats with oral doses of 0.66 mg
base/kg revealed no evidence of harm to the fetus due to brimonidine tartrate
ophthalmic solution 0.2%. Dosing at this level produced 100 times the plasma
drug concentration level seen in humans following multiple ophthalmic doses.There are no adequate and well-controlled studies in pregnant women. In
animal studies, brimonidine crossed the placenta and entered into the fetal
circulation to a limited extent. Brimonidine tartrate ophthalmic solution 0.2%
should be used during pregnancy only if the potential benefit to the mother
justifies the potential risk to the fetus.Nursing Mothers:It is not known whether this drug is excreted in human milk; in
animal studies brimonidine tartrate was excreted in breast milk. A decision
should be made whether to discontinue nursing or to discontinue the drug, taking
into account the importance of the drug to the mother.Pediatric Use:In a well-controlled clinical study conducted in pediatric
glaucoma patients (ages 2 to 7 years) the most commonly observed adverse events
with brimonidine tartrate ophthalmic solution 0.2% dosed three times daily were
somnolence (50% - 83% in patients ages 2 to 6 years) and decreased alertness. In
pediatric patients 7 years of age or older (>20kg), somnolence appears to
occur less frequently (25%). The most commonly observed adverse event was
somnolence. Approximately 16% of patients on brimonidine tartrate ophthalmic
solution discontinued from the study due to somnolence.The safety and effectiveness of brimonidine tartrate ophthalmic solution 0.2%
have not been studied in pediatric patients below the age of 2 years.
Brimonidine tartrate ophthalmic solution 0.2% is not recommended for use in
pediatric patients under the age of 2 years. (Also refer to Adverse Reactions
section).Geriatric Use:No overall differences in safety or effectiveness have been
observed between elderly and other adult patients.

Adverse Reactions:

Adverse events occurring in approximately 10-30% of the subjects,
in descending order of incidence, included oral dryness, ocular hyperemia,
burning and stinging, headache, blurring, foreign body sensation,
fatigue/drowsiness, conjunctival follicles, ocular allergic reactions, and
ocular pruritus.Events occurring in approximately 3-9% of the subjects, in descending order
included corneal staining/erosion, photophobia, eyelid erythema, ocular
ache/pain, ocular dryness, tearing, upper respiratory symptoms, eyelid edema,
conjunctival edema, dizziness, blepharitis, ocular irritation, gastrointestinal
symptoms, asthenia, conjunctival blanching, abnormal vision and muscular
pain.The following adverse reactions were reported in less than 3% of the
patients: lid crusting, conjunctival hemorrhage, abnormal taste, insomnia,
conjunctival discharge, depression, hypertension, anxiety,
palpitations/arrhythmias, nasal dryness and syncope.The following events have been identified during post-marketing use of
brimonidine tartrate ophthalmic solution 0.2% in clinical practice. Because they
are reported voluntarily from a population of unknown size, estimates of
frequency cannot be made. The events, which have been chosen for inclusion due
to either their seriousness, frequency of reporting, possible causal connection
to brimonidine tartrate ophthalmic solution 0.2%, or a combination of these
factors, include: bradycardia; hypotension; iritis; miosis; skin reactions
(including erythema, eyelid pruritis, rash, and vasodilation); and tachycardia.
Apnea, bradycardia, hypotension, hypothermia, hypotonia, and somnolence have
been reported in infants receiving brimonidine tartrate ophthalmic solution
0.2%.

Overdosage:

No information is available on overdosage in humans. Treatment of an oral
overdose includes supportive and symptomatic therapy; a patent airway should be
maintained.

Dosage And Administration:

The recommended dose is one drop of brimonidine tartrate
ophthalmic solution 0.2% in the affected eye(s) three times daily, approximately
8 hours apart.Brimonidine tartrate ophthalmic solution 0.2% may be used concomitantly with
other topical ophthalmic drug products to lower intraocular pressure. If more
than one topical ophthalmic product is being used, the products should be
administered at least 5 minutes apart.

How Supplied:

Brimonidine Tartrate Ophthalmic Solution 0.2% is supplied sterile
in a plastic bottle with a controlled drop tip in the following sizes:5 mL bottles – Prod. No. 4110710 mL bottles – Prod. No. 4110915 mL bottles – Prod. No. 41111Storage: Store between 15° – 25°C (59° –
77°F).KEEP OUT OF THE REACH OF CHILDREN.DO NOT USE IF IMPRINTED “Protective
Seal” WITH YELLOW (mortar and pestle symbol) IS NOT INTACT.Revised July 2008Bausch and Lomb IncorporatedTampa, FL
33637©Bausch and Lomb Incorporated9104701 (Folded) 9104601 (Flat)Prod. No. 411

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