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^�Yn�t�(�*;>���P�����@w��#�i��mE\� 4.1 . In this manner, the drug is released in ampoules of 2 mL containing 25 mg of clomipramine. Symptoms of brimonidine overdose have been reported in neonates, infants, and children receiving Carcinogenesis, Mutagenesis, Impairment of FertilityElevated IOP presents a major risk factor in glaucomatous field loss.
8.4 Pediatric Use ALPHAGAN® P is contraindicated in children under the age of 2 years (see CONTRAINDICATIONS, 4.1). Select one or more newsletters to continue.
The reactions, which have been chosen for inclusion due to either their seriousness, frequency of reporting, possible causal connection to brimonidine tartrate ophthalmic solutions, or a combination of these factors, include: bradycardia, depression, hypersensitivity, iritis, keratoconjunctivitis sicca, miosis, nausea, skin reactions (including erythema, eyelid pruritus, rash, and vasodilation), syncope, and tachycardia. The solution is indicated for both intramuscular and intravenous injections. 4.2 . These containers had been inadvertently contaminated by patients who, in most cases, had a concurrent corneal disease or a disruption of the ocular epithelial surface (see Because clinical studies are conducted under widely varying conditions, adverse reaction rates observed in the clinical studies of a drug cannot be directly compared to rates in the clinical studies of another drug and may not reflect the rates observed in practice.Adverse reactions occurring in approximately 10-20% of the subjects receiving brimonidine ophthalmic solution (0.1-0.2%) included: allergic conjunctivitis, conjunctival hyperemia, and eye pruritus.
PRECAUTIONS General: Although ALPHAGAN® P had minimal effect on the blood pressure of patients in
Because they are reported voluntarily from a population of unknown size, estimates of frequency cannot be made. <>
��~���R1J�&y���9��-�����w`�^��zYq����m�U��n6�|ੈ�! Approximately 87% of an orally-administered radioactive dose of brimonidine was eliminated within 120 hours, with 74% found in the urine.No compound-related carcinogenic effects were observed in either mice or rats following a 21-month and 24-month study, respectively.
from ALPHAGAN® P in nursing infants, 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. WebMD provides common contraindications for Alphagan P Ophthalmic (Eye). CONTRAINDICATIONS ALPHAGAN® P is contraindicated in patients with hypersensitivity to brimonidine tartrate or any component of this medication. Solution containing 1 mg/mL or 1.5 mg/mL brimonidine tartrate. Neonates and Infants (under the age of 2 years) ALPHAGAN ® is contraindicated in neonates and infants (under the age of 2 years) [see Use in Specific Populations (8.4)]. The highest doses of brimonidine tartrate in rats (2.5 mg/kg/day) and rabbits (5.0 mg/kg/day) achieved AUC exposure values 360- and 20-fold higher, or 260- and 15-fold higher, respectively, than similar values estimated in humans treated with There are no adequate and well-controlled studies in pregnant women; however, in animal studies, brimonidine crossed the placenta and entered into the fetal circulation to a limited extent. �vJC����2�x�wU9��)���%4�8��S���G�,�0��Ea�i%��m�9?��Nؾ彊�;�B�N)I�'������{�ꟈ�s qG|I] Find out what health conditions may be a health risk when taken with Alphagan P Ophthalmic (Eye) ALPHAGAN ® Eye Drops PI v5.0-ccds v2.1 3 mean decrease (+ SD) in IOP from baseline at 3 months, as measured at peak response, was 4.92 + 3.02 mmHg for brimonidine adjunctive therapy and 5.52 + 3.08 mmHg for pilocarpine adjunctive It is also contraindicated in patients receiving monoamine oxidase (MAO) inhibitor therapy.
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