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ZIMED PF is a brand name for Bimatoprost, supplied as a solution. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: ZIMED® PF (bimatoprost ophthalmic solution 0.03% w/v) is indicated for: • the reduction of elevated intraocular pressure in patients with open angle glaucoma or ocular hypertension 1.1 Pediatrics Pediatrics (<18 years of age): No data are available to Health Canada; therefore, Health Canada has not authorized an…
Verbatim from this product's HC label. Tap a section to expand.
1 Dosing Considerations Patients with a history of contact hypersensitivity to silver should not use this product as dispensed drops may contain traces of silver (see 2 CONTRAINDICATIONS). 2 Recommended Dose and Dosage Adjustment The recommended dosage is one drop in the affected eye(s) once daily in the evening.
The dosage of ZIMED® PF should not exceed once daily since it has been shown that more frequent administration of bimatoprost ophthalmic solution may lessen the intraocular pressure lowering effect and increase the frequency and severity of adverse events.
(see 7 WARNINGS and PRECAUTIONS, Ophthalmologic). 1 Pediatrics (< 18 years of age)).
Hepatic Impairment:
ZIMED® PF has not been studied in patients with moderate to severe hepatic impairment and should therefore be used with caution in such patients (see 7 WARNINGS AND PRECAUTIONS, Hepatic/Biliary/Pancreatic). 03% w/v) Page 5 of 26 Renal Impairment: ZIMED® PF has not been studied in patients with renal impairment and should therefore be used with caution in such patients (see 7 WARNINGS AND PRECAUTIONS, Renal).
4 Administration If more than one topical ophthalmic drug is being used, the drugs should be administered at least five (5) minutes apart. Contact lenses should be removed prior to instillation of ZIMED® PF and may be reinserted 15 minutes following its administration.
5 Missed Dose Patients should be instructed to apply a single drop as soon as they remember, and then to return to their regular routine.
03% (with benzalkonium chloride) once-daily for 12 weeks demonstrated that the two formulations had similar safety profiles. 9% of patients treated). 2 Clinical Trial Adverse Reactions Clinical trials are conducted under very specific conditions.
The adverse reaction rates observed in the clinical trials; therefore, may not reflect the rates observed in practice and should not be compared to the rates in the clinical trials of another drug. Adverse reaction information from clinical trials may be useful in identifying and approximating rates of adverse drug reactions in real-world use.
The data presented below are taken from a randomized, multicenter, double-masked, parallel-group clinical study, of 12 weeks duration, which was conducted in 597 patients with glaucoma or ocular hypertension. 0%), regardless of causality, is presented in Table 2.
1%). The most frequent treatment-related adverse events were conjunctival hyperaemia, eye pruritus, and punctate keratitis. The majority of cases of hyperaemia were graded as trace to mild on macroscopic evaluation. No safety concerns were noted from other ocular assessments.
0% (3/295) in the bimatoprost group. 5 Post-Market Adverse Reactions The following adverse reactions have been identified during post-marketing use of bimatoprost preservative-free. Because post-marketing reporting is voluntary and from a population of uncertain size, it is not possible to reliably estimate the frequency of these reactions.
Eye Disorders:
Eye discharge, ocular discomfort, macular edema, erythema (periorbital) , blepharitis, eye swelling, eyelid irritation, eyelid pain, blepharal pigmentation, eye edema, periorbital and lid changes associated with periorbital fat atrophy and skin tightness resulting in deepening of the eyelid sulcus, eyelid ptosis, enophthalmos and eyelid retraction, prostaglandin analogue periorbitopathy, conjunctival disorder.
, Hepatic/Biliary/Pancreatic). 03% w/v) Page 5 of 26 Renal Impairment: ZIMED® PF has not been studied in patients with renal impairment and should therefore be used with caution in such patients (see 7 WARNINGS AND PRECAUTIONS, Renal).
4 Administration If more than one topical ophthalmic drug is being used, the drugs should be administered at least five (5) minutes apart. Contact lenses should be removed prior to instillation of ZIMED® PF and may be reinserted 15 minutes following its administration.
5 Missed Dose Patients should be instructed to apply a single drop as soon as they remember, and then to return to their regular routine. 5 OVERDOSAGE No information is available on overdosage in humans. If overdose with ZIMED® PF occurs, treatment should be symptomatic.
In short-term oral (by gavage) mouse and rat studies, doses up to 100 mg/kg/day did not produce any toxicity. This dose, expressed as mg/m2, is at least 100 times higher than the amount of bimatoprost to which a 10 kg child would be exposed were it to ingest the entire contents of a bottle of ZIMED® PF.
For management of a suspected drug overdose, contact your regional Poison Control Centre. 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING Table 1 Dosage Forms, Strengths, Composition and Packaging ZIMED® PF is a sterile preservative-free ophthalmic solution.
3 mg. ZIMED® PF is supplied sterile in a 5 mL bottle manufactured from LDPE, equipped with the Novelia® one-way valve and PureFlow® technology system. 03% w/v Citric acid monohydrate, disodium hydrogen phosphate heptahydrate, water, sodium chloride.
Sodium hydroxide and/or hydrochloric acid may be added to adjust pH. 03% w/v) Page 6 of 26 with silver ions to prevent bacterial growth. Each bottle of 3 mL sufficient for 4 week’s treatment. 7 WARNINGS AND PRECAUTIONS General Bimatoprost ophthalmic solutions have been reported to cause changes to pigmented tissue.
ZIMED® PF is contraindicated in patients who are hypersensitive to this drug or to any ingredient in the formulation, including any non-medicinal ingredient, or component of the container. For a complete listing, see section 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING.
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
Other brands of Bimatoprost in Canada.
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Gastrointestinal disorders: nausea General disorders and administration site conditions: instillation site irritation Immune System Disorders: Hypersensitivity reaction including signs and symptoms of eye allergy and allergic dermatitis Nervous System Disorders: Dizziness Respiratory, Thoracic and Mediastinal Disorders: Asthma, exacerbation of asthma, dyspnea, COPD exacerbation Skin and subcutaneous tissue disorders: hair growth abnormal, burning sensation (eyelid), madarosis (temporary loss of a few eyelashes to loss of sections of eyelashes), rash (including macular, erythematous, and pruritic limited to the eyelids and periorbital region), trichorrhexis (temporary eyelash breakage), dry skin of the eyelid and/or periolar area, hordeolum, trichiasis, hypertrichosis, eyelid margin crusting, skin discoloration (periocular).
Vascular Disorders:
Hypertension
The changes include increased pigmentation and growth of eyelashes and increased pigmentation of the iris and periorbital tissue (eyelid). The increased pigmentation may be permanent. ZIMED® PF may gradually change eye colour, increasing the amount of brown pigment in the iris by increasing the number of melanosomes (pigment granules) in melanocytes.
The long- term effects on the melanocytes and the consequences of potential injury to the melanocytes and/or deposition of pigment granules to other area of the eye are currently unknown. The change in iris colour occurs slowly and may not be noticeable for several months to years.
Pigmentation is expected to increase as long as bimatoprost ophthalmic solution is administered. 1% of patients treated for 6 months). Patients should be informed of the possibility of iris colour change. In addition, patients who are expected to receive treatment in only one eye should be informed about the potential for increased brown pigmentation of the iris, periorbital tissue, and eyelashes in the treated eye and thus, heterochromia between the eyes.
They should be advised of the potential for a disparity between the eyes in length, thickness, and/or number of eyelashes. Typically, the brown pigmentation around the pupil is expected to spread concentrically towards the periphery in affected eyes, but the entire iris or parts of it may also become more brownish.
Until more information about increased brown pigmentation is available, patients should be examined regularly and, depending on the clinical situation, treatment may be stopped if increased pigmentation ensues. The increase in brown iris pigment is not expected to progress further upon discontinuation of treatment, but the resultant colour change is likely to be permanent.
Neither nevi nor freckles of the iris are expected to be affected by treatment. There is the potential for hair growth to occur in areas where bimatoprost solution comes repeatedly in contact with the skin surface. Thus, it is important to apply bimatoprost as instructed and to avoid it running onto the cheek or other skin areas.
Patients with a history of contact hypersensitivity to silver should not use this product as dispensed drops may contain traces of silver. 03% w/v) Page 7 of 26 Carcinogenesis and Mutagenesis See 16 NON-CLINICAL TOXICOLOGY. Driving and Operating Machinery Based on the pharmacodynamic profile, bimatoprost is not expected to influence a patient’s ability to drive or operate machinery.
As with any ocular medication, if transient blurred vision occurs at instillation, the patient should wait until the vision clears before driving or using machinery. Hepatic/Biliary/Pancreatic ZIMED® PF has not been studied in patients with moderate to severe hepatic impairment and should therefore be used with caution in such patients.
05 mg/mL as preservative) had no adverse effect on liver function over 48 months. , uveitis) because the inflammation may be exacerbated. 03% (with benzalkonium […]