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Tapcom: Careful administration (This product should be administered with care to the following patients): Patients with right ventricular failure caused by pulmonary hypertension (Symptoms may be aggravated due to negative chronotropic/inotropic effects caused by β-receptor blockage).
Patients with congestive heart failure (Symptoms may be aggravated due to negative chronotropidinotropic effects caused by β-receptor blockage).
Patients with diabetic ketoacidosis or metabolic acidosis (This product may enhance the depression of myocardial contraction caused by acidosis).
Patients with poor-controlled diabetes (Pay attention to the blood glucose level because this product may mask hypoglycemia).
Patients with aphakia or pseudophakia (Other drugs in this category have been reported to induce macular oedema including cystoid macular oedema, and associated visual acuity reduction).
Patients with intraocular inflammation (iritis, uveitis) (Other drugs in this category have been reported to cause elevation of intraocular pressure).
Pregnant, parturient and lactating women (See Use in Pregnancy & Lactation).
Important precautions: This product is a combination ophthalmic solution containing 15 µg/mL of tafluprost and 6.83 mg/mL of timolol maleate equivalent to timolol 5 mg/mL. Use this product appropriately because adverse drug reactions may be induced by both of the above active ingredients.
This product may be absorbed systemically, and cause adverse drug reactions similar to those caused by systemic administration of a β-blocker.
Pigmentation in iris and eyelid (increased melanin content), or hypertrichosis around the eyes may occur. These symptoms gradually progress with continued administration, and stop when treatment is discontinued. Symptoms like blepharal pigmentation and hypertrichosis around the eyes can gradually disappear or diminish after administration is discontinued, however, there are reports that iris pigmentation persisted even after administration was discontinued. In such cases, iris color change can be detected clearly in patients with mixed-color irises and even in patients with single-color dark brown irises (seen among most Japanese) as well. The difference in iris color between right and left eyes could be noted particularly in the case of unilateral administration. As long-term observation data about these symptoms arc not yet available, doctors are required to closely observe patients through periodic checkups. Patients should be well informed of the possibility of these symptoms and instructed to wipe off any excess solution from the skin around the eye or to wash their faces in order to prevent blepharal pigmentation or hypertrichosis around eyes.
Corneal epithelium disorder (superficial punctate keratitis, filamentary keratitis or corneal erosion) may occur during treatment. Instruct patients to consult a doctor immediately if symptoms including eye stinging, itching, and eye pain continue.
This product should be administered carefully, because there is no clinical experience in patients with closed angle glaucoma.
Pay close attention when medication is switched from a miotic to this product. This is because the switch from a miotic to timolol maleate may require refraction adjustment due to loss of miotic action.
Temporary blurred vision may develop after administration of this product. Instruct patients to refrain from activities including driving or operating machinery until the symptom disappears.
Tapcom-S: Systemic effects: Like other topically applied ophthalmic agents, tafluprost and timolol are absorbed systemically. Due to the beta-adrenergic component timolol, the same types of cardiovascular, pulmonary and other adverse reactions as seen with systemic beta-adrenergic blocking agents may occur. Incidence of systemic adverse reactions after topical ophthalmic administration is lower than for systemic administration. To reduce the systemic absorption, see Dosage & Administration.
Cardiac disorders: In patients with cardiovascular diseases (e.g. coronary heart disease, Prinzmetal's angina and cardiac failure) and hypotension, therapy with beta-blockers should be critically assessed and the therapy with other active substances should be considered. Patients with cardiovascular diseases should be watched for signs of deterioration of these diseases and of adverse reactions.
Due to its negative effect on conduction time, beta-blockers should only be given with caution to patients with first degree heart block.
Vascular disorders: Patients with severe peripheral circulatory disturbance/disorders (i.e. severe forms of Raynaud's disease or Raynaud's syndrome) should be treated with caution. Respiratory disorders: Respiratory reactions, including death due to bronchospasm in patients with asthma have been reported following administration of some ophthalmic beta-blockers. TAPCOM-S should be used with caution, in patients with mild/moderate chronic obstructive pulmonary disease (COPD) and only if the potential benefit outweighs the potential risk.
Hypoglycemia/diabetes: Beta-blockers should be administered with caution in patients subject to spontaneous hypoglycaemia or to patients with labile diabetes, as beta-blockers may mask the signs and symptoms of acute hypoglycaemia.
Beta-blockers may also mask the signs of hyperthyroidism. Abrupt withdrawal of beta -blocker therapy may precipitate a worsening of symptoms.
Corneal diseases: Ophthalmic beta-blockers may induce dryness of eyes. Patients with corneal diseases should be treated with caution.
Other beta-blocking agents: The effect on intra-ocular pressure or the known effects of systemic beta-blockade may be potentiated when timolol (a component of TAPCOM-S) is given to the patients already receiving a systemic beta-blocking agent. The response of these patients should be closely observed. The use of two topical beta-adrenergic blocking agents is not recommended.
Angle-closure glaucoma: In patients with angle-closure glaucoma, the immediate objective of treatment is to reopen the angle. This requires constricting the pupil with a miotic. Timolol has little or no effect on the pupil. When timolol is used to reduce elevated intraocular pressure in angle-closure glaucoma it should be used with a miotic and not alone.
Anaphylactic reactions: While taking beta-blockers, patients with a history of atopy or a history of severe anaphylactic reaction to a variety of allergens may be more reactive to repeated challenge with such allergens and unresponsive to the usual doses of adrenaline used to treat anaphylactic reactions.
Choroidal detachment: Choroidal detachment has been reported with administration of aqueous suppressant therapy (e.g. timolol, acetazolamide) after filtration procedures.
Surgical anaesthesia: Beta-blocking ophthalmological preparations may block systemic beta-agonist effects e.g. of adrenaline. The anaesthesiologist should be informed when the patient is receiving timolol.
Before treatment is initiated, patients should be informed of the possibility of eyelash growth, darkening of the eyelid skin and increased iris pigmentation which are related to tafluprost therapy. Some of these changes may be permanent, and may lead to differences in appearance between the eyes when only one eye is treated.
The change in iris pigmentation occurs slowly and may not be noticeable for several months. The change in eye colour has predominantly been seen in patients with mixed coloured irises, e.g. blue-brown, grey-brown, yellow-brown and green-brown. The risk of lifelong heterochromia between the eyes in unilateral cases is obvious.
There is no experience with tafluprost in neovascular, angle-closure, narrow-angle or congenital glaucoma. There is only limited experience with tafluprost in aphakic patients and in pigmentary or pseudoexfoliative glaucoma.
Caution is recommended when using tafluprost in aphakic patients, pseudophakic patients with torn posterior lens capsule or anterior chamber lenses, or in patients with known risk factors for cystoid macular oedema or iritis/uveitis.
Use in Children: Tapcom: The safety of this product in low-birth-weight infants, neonates, infants or children has not been established. (No clinical experience.)
Use in Elderly: Tapcom: Because physiological function is generally reduced in the elderly, caution should be exercised.
