Rimoflo™soft_pi

For the use of an Registered Medical Practitioner or a Hospital or a Laboratory only USE IN SPECIAL POPULATIONS
Teratogenic Effects
Pregnancy Category B: Teratogenicity studies have been performed in
animals. Brimonidine tartrate was not teratogenic when given orally
Rimoflo ™ Soft
during gestation days 6 through 15 in rats and days 6 through 18 in (Brimonidine Tartrate Ophthalmic Solution 0.15% w/v) rabbits. 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- GENERIC NAME
fold higher, or 260- and 15-fold higher, respectively, than similar values Brimonidine Tartrate Ophthalmic Solution 0.15% w/v estimated in humans treated with Brimonidine Tartrate Ophthalmic Solution, 1 drop in both eyes three times daily.
DOSAGE FORM
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. Because animal reproduction studies are not always predictive of human response, Rimoflo ™ Soft Rimoflo™ Soft (Brimonidine Tartrate Ophthalmic Solution 0.15% w/v) (Brimonidine Tartrate Ophthalmic Solution 0.15% w/v) should be used sterile, is a relatively selective alpha-2 adrenergic receptor agonist during pregnancy only if the potential benefit to the mother justifies the (topical intraocular pressure lowering agent). The structural formula of potential risk to the foetus.
brimonidine tartrate is: It is not known whether brimonidine tartrate is excreted in human milk, although in animal studies, brimonidine tartrate has been shown to be excreted in breast milk. Because of the potential for serious adverse reactions from Brimonidine Tartrate Ophthalmic Solution 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.
5-Bromo-6-(2-imidazolidinylideneamino) quinoxaline L-tartrate; MW= Brimonidine Tartrate Ophthalmic Solution is contraindicated in children under the age of 2 years. During postmarketing surveillance, apnea, bradycardia, coma, hypotension, hypothermia, hypotonia, lethargy,pallor, In solution, Rimoflo ™ Soft (Brimonidine Tartrate Ophthalmic Solution respiratory depression, and somnolence have been reported in infants 0.15% w/v) has a clear, greenish-yellow color. It has an osmolality of 250- receiving brimonidine. The safety and effectiveness of brimonidine 350 mOsmol/kg and a pH of 6.9-7.4 (0.15%).
tartrate have not been studied in children below the age of 2 years.
Brimonidine tartrate appears as an off-white to pale-yellow powder and is In a well-controlled clinical study conducted in pediatric glaucoma patients soluble in both water (0.6 mg/mL) and in the product vehicle (1.4 mg/mL) (ages 2 to 7 years) the most commonly observed adverse reactions with Brimonidine tartrate ophthalmic solution 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 (>20 kg), somnolence Active: Brimonidine Tartrate 0.15% w/v appears to occur less frequently (25%). Inactive Ingredients: Sodium CMC, Sodium Chlorite (Oxychloro Complex), Boric Acid, Borax, Potassium Chloride, Calcium Chloride Dihydrate, Magnesium Chloride (Hexahydrate), Sodium Hydroxide, No overall differences in safety or effectiveness have been observed Water for Injection IP between elderly and other adult patients.
Preservative Added: Stabilised Oxychloro Complex 0.005% w/v INDICATIONS
No studies are available for use of Brimonidine Tartrate Ophthalmic Rimoflo ™ Soft is indicated for lowering of intraocular pressure in patients Solution in patients with hepatic impairment.
with open angle glaucoma or ocular hypertension DOSAGE AND ADMINISTRATION
Brimonidine Tartrate Ophthalmic Solution has not been studied in patients The recommended dose is one drop of Rimoflo ™ Soft (Brimonidine with renal impairment. The effect of dialysis on brimonidine Tartrate Ophthalmic Solution 0.15% w/v) in the affected eye(s) three pharmacokinetics in patients with renal failure is not known.
times daily, approximately 8 hours apart. Rimoflo ™ Soft (Brimonidine Tartrate Ophthalmic Solution 0.15% w/v) may be used concomitantly with other topical ophthalmic drug products to lower intraocular pressure. If Rimoflo™ Soft is contraindicated in neonates and infants (under the age more than one topical ophthalmic product is to be used, the different of 2 years).
products should be instilled at least 5 minutes apart. Rimoflo™ Soft is contraindicated in patients with known hypersensitivity reactions occurring in approximately 5-9% included: burning sensation, to any ingredient in the formulation.
conjunctival folliculosis, hypertension, ocular allergic reaction, oral dryness, and visual disturbance.
WARNINGS AND PRECAUTIONS
Adverse reactions occurring in approximately 1-4% of the subjects FOR EXTERNAL USE ONLY. NOT FOR INJECTION
receiving brimonidine ophthalmic solution (0.1-0.2%) included: abnormal taste, allergic reaction, asthenia, blepharitis, blepharoconjunctivitis, Potentiation of Vascular Insufficiency
blurred vision, bronchitis, cataract, conjunctival edema, conjunctival Brimonidine Tartrate Ophthalmic Solution may potentiate syndromes hemorrhage, conjunctivitis, cough, dizziness, dyspepsia, dyspnea, associated with vascular insufficiency. Brimonidine Tartrate Ophthalmic epiphora, eye discharge, eye dryness, eye irritation, eye pain, eyelid Solution should be used with caution in patients with depression, cerebral edema, eyelid erythema, fatigue, flu syndrome, follicular conjunctivitis, or coronary insufficiency, Raynaud's phenomenon, orthostatic foreign body sensation, gastrointestinal disorder, headache, hypotension, or thromboangiitis obliterans.
hypercholesterolemia, hypotension, infection (primarily colds and respiratory infections), insomnia, keratitis, lid disorder, pharyngitis, Severe Cardiovascular Disease
photophobia, rash, rhinitis, sinus infection, sinusitis, somnolence, Brimonidine Tartrate Ophthalmic Solution has been shown to produce stinging, superficial punctate keratopathy, tearing, visual field defect, minimal effect on the blood pressure of patients in clinical studies, still vitreous detachment, vitreous disorder, vitreous floaters, and worsened caution should be exercised in treating patients with severe visual acuity.
The following reactions were reported in less than 1% of subjects: corneal Contamination of Topical Ophthalmic Products After Use
erosion, hordeolum, nasal dryness, and taste perversion.
There have been reports of bacterial keratitis associated with the use of multiple-dose containers of topical ophthalmic products. These Post Marketing Experience
containers had been inadvertently contaminated by patients who, in most The following reactions have been identified during postmarketing use of cases, had a concurrent corneal disease or a disruption of the ocular brimonidine tartrate ophthalmic solutions include: bradycardia, epithelial surface.
depression, hypersensitivity, iritis, keratoconjunctivitis sicca, miosis, nausea, skin reactions (including erythema, eyelid pruritus, rash, and DRUG INTERACTIONS
vasodilation), syncope, and tachycardia. Apnea, bradycardia, coma, hypotension, hypothermia, hypotonia, lethargy, pallor, respiratory Rimoflo™ Soft (Brimonidine Tartrate Ophthalmic Solution 0.15% w/v) depression, and somnolence have been reported in infants receiving may reduce blood pressure, henceforth caution in using drugs such as brimonidine tartrate ophthalmic solutions.
antihypertensives and/or cardiac glycosides with Rimoflo™ Soft (Brimonidine Tartrate Ophthalmic Solution 0.15% w/v) is advised.
PHARMACODYNAMIC AND PHARMACOKINETIC PROPERTIES
Although specific drug interaction studies have not been reported with Brimonidine Tartrate Ophthalmic Solution the possibility of an additive or Mechanism of Action:
potentiating effect with CNS depressants (alcohol, barbiturates, opiates, Brimonidine tartrate is a relatively selective alpha-2 adrenergic receptor sedatives, or anesthetics) should be considered.
agonist with 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 Tricyclic antidepressants have been reported to blunt the hypotensive humor production and increasing uveoscleral outflow.
effect of systemic clonidine. It is not known whether the concurrent use of these agents with Brimonidine tartrate ophthalmic solution in humans can lead to resulting interference with the IOP lowering effect. Caution is advised in patients taking tricyclic antidepressants which can affect the After ocular administration of either a 0.1% or 0.2% solution, plasma metabolism and uptake of circulating amines.
concentrations peaked within 0.5 to 2.5 hours and declined with a systemic half-life of approximately 2 hours.
Monoamine Oxidase Inhibitors
Monoamine oxidase (MAO) inhibitors may theoretically interfere with the The protein binding of brimonidine has not been studied.
metabolism of brimonidine and potentially result in an increased systemic side-effect such as hypotension. Caution is advised in patients taking In humans, brimonidine is extensively metabolized by the liver.
MAO inhibitors which can affect the metabolism and uptake of circulating Urinary excretion is the major route of elimination of brimonidine and its metabolites. Approximately 87% of an orally-administered radioactive UNDESIRABLE EFFECTS
dose of brimonidine was eliminated within 120 hours, with 74% found in the urine.
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. Adverse STORAGE AND HANDLING INSTRUCTIONS
Elevated IOP presents a major risk factor in glaucomatous field loss. The higher the level of IOP, the greater the likelihood of optic nerve damage Keep in a cool place. Protect from light. DO NOT FREEZE. and visual field loss. Brimonidine tartrate has the action of lowering Use the solution within one month after opening the container.
intraocular pressure with minimal effect on cardiovascular and pulmonary parameters.Clinical studies were conducted to evaluate the safety, KEEP ALL MEDICINES OUT OF REACH OF CHILDREN
efficacy, and acceptability of brimonidine tartrate ophthalmic solution 0.15% compared with brimonidine tartrate ophthalmic solution 0.2%, administered three-times-daily in patients with open-angle glaucoma or ocular hypertension. Those results indicated that brimonidine tartrate PI of Alphagan-P, Allergan, 06/2011 Information complied in ophthalmic solution 0.15% is comparable in IOP lowering effect to brimonidine tartrate ophthalmic solution 0.2%, and effectively lowers IOP in patients with open-angle glaucoma or ocular hypertension by approximately 2-6 mmHg.
Tips for Safe Administration of Eye Drops
OVERDOSE
Very limited information exists on accidental ingestion of brimonidine in
adults; the only adverse reaction reported to date has been hypotension. Symptoms of brimonidine overdose have been reported in neonates, infants, and children receiving Brimonidine Tartrate Ophthalmic Solution as part of medical treatment of congenital glaucoma or by accidental oral ingestion. Treatment of an oral overdose includes supportive and symptomatic therapy; a patent airway should be maintained.
INFORMATION FOR PATIENTS Rimoflo™ Soft is sterile when packed. Patient are advised not to allow the dropper tip/ dispensing tip to touch any surface, as this may 1. Wash your hands thoroughly before administration.
contaminate the solution by common bacteria known to cause ocular 2. Bend your head backwards and gently pull your lower eyelid down.
infections. Serious damage to the eye and subsequent loss of vision 3. Turn the bottle upside down and squeeze it to release one drop into may result from using contaminated solutions.
each eye that needs treatment.
If solution changes color or becomes cloudy, it is advised that patients 4. Let go of the lower lid, and close your eye for 30 seconds.
must not use it. 5. Wipe away any liquid that falls onto your cheek with a tissue.
Do not use the product after the expiration date marked on the bottle.
6. Close the cap immediately after use.
If patients have ocular surgery or develop an intercurrent ocular Take Care of your eye drops:
condition (e.g. trauma or infection), immediately seek physician's Ÿ Do not let the dropper or dispensing tips touch your eye, finger, or any advice concerning the continued use of the present multidose other surface.
Ÿ This medicine has been prescribed for you. Do not pass it on to others. If more than one topical ophthalmic drug is being used, the drugs It may harm them, even if their symptoms are the same as yours.
should be administered at least five minutes apart and only after Ÿ If more than one type of Eye Drops are used, wait for at least five consultation with medical practitioner.
minutes before administering the second medication to avoid washout As with other similar medications, Rimoflo™ Soft may cause fatigue of the previous drug.
and/or drowsiness in some cases.
Ÿ Consult your physician if eye symptoms become worse after using eye Patients who engage in hazardous activities are cautioned of the potential for a decrease in mental alertness.
Read this entire leaflet carefully before you start using this medicine. Keep this leaflet. You may need to read it again. If you have any further questions, ask your Physician. No incompatibility studies are reported.
Marketed by:
BAUSCH & LOMB EYECARE (I) PVT. LTD.
SHELF LIFE
R-13 & 14, Ansal Chambers–II, Please see Mfg. Date/ Expiry Date printed on pack. Do not use the product 6 Bhikaji Cama Place, after the expiry date which is stated on the packaging. The expiry date refers to the last day of that month.
Manufactured in India by: Micro Labs Limited Plot No: 113 to 116, 4th Phase; Rimoflo ™ Soft (Brimonidine Tartrate Ophthalmic Solution 0.15% w/v) are K.I.A.D.B., Bommasandra Industrial Area, supplied in a 5 ml plastic bottle with a white cap.
®/TM are trademarks of Bausch & Lomb or its affiliatesAll other product / brand names are trademarks of their respective owners.

Source: http://www.bausch.in/-/m/BL/India/Files/Package%20Inserts/Pharma/rimoflo-soft_pi-full-length.pdf