Buy Taptiqom eye drops 0.0015% + 0.5% 0.3 ml 30 ml
  • Buy Taptiqom eye drops 0.0015% + 0.5% 0.3 ml 30 ml

Taptiqom®

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2019-09-19
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Clinical Pharmacology

Tapticom ® is a combined preparation containing two active ingredients - tafluprost and timolol. These two active substances reduce intraocular pressure (IOP) through additional mechanisms of action, and the combined action results in an additional decrease in IOT compared to the action of only one of the two substances.
Tafluprost is a fluorinated analogue of prostaglandin F 2ɑ. Tafluprost acid, a biologically active metabolite of tafluprost, is a highly active selective antagonist of the human PROSTANOID FP receptor.
Pharmacodynamic studies in animals show that tafluprost reduces intraocular pressure by increasing the uveoscleral outflow of eye fluid.
Timolol maleate is a non-selective beta-adrenergic receptor. The exact mechanism of action of timolol maleate in lowering intraocular pressure is not yet fully understood, although studies on fluorescein and studies using tonography indicate that the main effect may be associated with reduced formation of fluid. However, some studies also showed a slight increase in outflow activation.

Indications

Reduction of intraocular pressure (IOP) in adult patients with open-angle glaucoma or ophthalmic hypertension who do not respond well to local monotherapy with beta-blockers or prostaglandin analogs and require combination therapy and who are shown to use preservative-free eye drops.

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Taptiqom®

Dosage and Administration

The recommended therapy is to instill 1 eye drop into the conjunctival sac of the affected eye (s) once a day.
If a dose is missed, treatment should be continued with the next dose as planned. The dose should not exceed one drop in the affected eye (s) 1 time per day.
Tapticom ® is a sterile solution without preservatives. Designed for single use only, one dropper tube is sufficient to treat both eyes. Any unused solution or its residues must be disposed of immediately.
Elderly patients
There is no need to change the dosage in elderly patients.
Renal and hepatic failure
The use of tafluprost and timolol eye drops in patients with renal / hepatic insufficiency has been investigated, therefore the drug Tapticom should be used with caution in such patients.
mode of application
ophthalmic use
To reduce the risk of darkening of the eyelid skin, patients should wipe excess fluid from the skin.
With nasolacrimal occlusion or eyelid closure within 2 minutes, systemic absorption is reduced, which can result in a decrease in systemic side effects and an increase in local activity.
If more than one ophthalmic drug is prescribed, the interval between instillation of each of these drugs should be at least 5 minutes.
Contact lenses must be removed before applying the eye drops and wait at least 15 minutes before they can be put back on.
Patients should be advised to avoid direct eye contact with the vial as this could result in eye injury.
Patients should also be advised that ophthalmic solutions, if handled improperly, may become contaminated with common bacteria known to cause eye infections. The use of contaminated solutions can result in severe eye damage and subsequent loss of vision.
Children.
The safety and efficacy of Tapticom ® for children (under the age of 18) have not been established. Data are not available. Tapticom ® is not used in children.

Adverse reactions

In clinical trials, more than 484 patients were treated with Tapticom®. A common reported treatment-related adverse reaction was conjunctival / hyperemia. It occurred in about 7% of patients participating in clinical trials; in most cases it was mild, and in 1.2% of patients it was associated with discontinuation of treatment.
Adverse reactions reported in clinical trials using Tapticom® were limited to those previously reported with one of the active ingredients, tafluprost or timolol. No new adverse reactions characteristic of Tapticom ® have been observed in clinical studies. Most of the adverse reactions reported were ocular, mild to moderate, and not serious.
Like other topical ophthalmic preparations, tafluprost and timolol are absorbed systemically. This can cause similar adverse reactions seen with systemic beta blockers. The incidence of systemic adverse reactions after topical application of ophthalmic drugs is lower than with systemic use. The following adverse reactions include those reactions that have been observed within the class of ophthalmic beta-blockers.
These adverse reactions have been reported when taking Tapticom ® in clinical trials (within each group below, in terms of frequency of occurrence, adverse reactions are presented in decreasing order of frequency).
The frequency of possible adverse reactions listed below was determined using the following conventions: very often (≥1 / 10); often (≥ 1/100 to <1/10); infrequently (≥1 / 1,000 to <1/100); rarely (≥1 / 10,000 to <1 1="" 000="" very="" rarely="" 10="" unknown="" frequency="" cannot="" be="" determined="" based="" on="" existing="" data="" br=""> Tapticom ® (tafluprost / timolol combination)
From the nervous system
Uncommon: headache
On the part of the organs of vision
Often: conjunctiva / hyperemia, itchy eyes, eye pain, eyelash changes (increase in length, thickness and number of eyelashes), eyelash discoloration, eye irritation, foreign body sensation in the eyes, blurred vision, photophobia (photophobia).
Uncommon: unusual sensation in the eyes, dry eyes, discomfort in the eyes, conjunctivitis, erythema of the eyelids, eye allergies, edema of the eyelids, superficial punctate keratitis, increased lacrimation, inflammation of the anterior chamber of the eye, asthenopia (fatigue of the eyes), blepharitis (inflammation of the eyelids).
Additional side reactions that were observed with the use of one of the active substances (tafluprost or timolol), and may also occur with the use of Tapticom ®, are listed below.
Tafluprost
From the side of the organs of vision: Decreased visual acuity, increased pigmentation of the iris, pigmentation of the eyelids, edema of the conjunctiva, discharge from the eyes, cellular moisture reaction of the anterior chamber, cellular opalescence in the anterior chamber of the eye, allergic conjunctivitis, pigmentation of the conjunctiva, conjunctival follicles, deepening of the furrow iritis (inflammation of the iris) / uveitis (inflammation of the choroid).
On the part of the skin and its derivatives: hypertrichosis of the eyelids.
From the respiratory system: exacerbation of bronchial asthma, shortness of breath (shortness of breath / shortness of breath).
timolol
From the immune system: signs and symptoms of allergic reactions, including angioedema, urticaria, single and multiple rashes, anaphylactic reaction, itching.
From the side of metabolism and nutrition: hypoglycemia.
From the side of the psyche: depression, sleep disturbance (insomnia), nightmares, memory loss, nervousness.
From the nervous system: dizziness, fainting, paresthesias, increased myasthenia gravis, hemorrhagic stroke, cerebral ischemia.
From the side of the organs of vision: keratitis, decreased sensitivity of the cornea, visual disturbances and disorders, including changes in refraction (due to the cancellation of miotic agents in some cases), ptosis (drooping of the eyelid), diplopia (double vision), choroidal detachment after filtering surgery, lacrimation, corneal erosion.
On the part of the hearing and balance organs: ringing / noise in the ears.
From the heart: bradycardia, chest pain, heart palpitations, edema, arrhythmia, congestive heart failure, cardiac arrest, heart block, blockade, heart failure.
From the side of the vessels: hypotension, lameness, Raynaud's disease, cold extremities (hands and feet).
From the respiratory system, chest and mediastinal organs: shortness of breath (shortness of breath / shortness of breath), bronchospasm (especially in patients with a pre-existing bronchospastic disease), respiratory failure, cough.
From the digestive system: nausea, dyspepsia (indigestion), diarrhea, dry mouth, dysgeusia (disorder of taste), abdominal pain, vomiting.
On the part of the skin and its derivatives: alope

Drug interactions

No special studies of interaction with other drugs have been conducted. Potential additional effects resulting in hypotension and / or severe bradycardia when a beta-blocker ophthalmic solution is used concomitantly with oral calcium channel blockers, beta-blockers, antiarrhythmics (including amiodarone), digitalis glycosides, parasympathomimetics, guanethidine. Oral beta-blockers can increase "rebound" hypertension that occurs after the withdrawal of clonidine. Increased effects of systemic beta-blockers (eg, decreased heart rate, depression) have been reported during combination treatment with CYP2D6 inhibitors (such as quinidine, fluoxetine, paroxetine) and timolol. Rarely reported mydriasis caused by the concomitant use of ophthalmic beta-blockers and epinephrine (epinephrine).

Pregnancy and Lactation

Use of the drug during pregnancy is contraindicated.

There is not enough data on whether tamoxifen penetrates into breast milk, so during lactation you should not use the drug or you need to decide whether to stop breastfeeding.

Special instructions

Women receiving tamoxifen should undergo regular gynecological examination. When a bloody discharge from the vagina or vaginal bleeding occurs, the drug should be stopped.

In patients with bone metastases, the concentration of calcium in the serum should be determined periodically during the initial period of treatment. In case of pronounced disorders, tamoxifen should be temporarily stopped.

If there are signs of venous thrombosis of the lower extremities (pain in the legs or their swelling), pulmonary embolism (shortness of breath), the drug should be stopped. Tamoxifen can cause ovulation, which increases the risk of pregnancy, and therefore, it is recommended to use a mechanical or non-hormonal contraceptive during tamoxifen treatment for women who have an active sex life. During the period of therapy, it is necessary to periodically monitor blood coagulation parameters, calcium content in the blood, blood picture (leukocytes, platelets), indicators of liver function, blood pressure, to be examined by an oculist.

In patients with hyperlipidemia in the course of treatment it is necessary to control the concentration of cholesterol and triglycerides in the blood serum.

Impact on the ability to drive vehicles and other mechanisms that require high concentration of attention

During the period of treatment, it is necessary to refrain from engaging in potentially hazardous activities that require an increased concentration of attention and quickness of psychomotor reactions.

Overdosage

Overdose with topical application of tafluprost is unlikely to occur or be associated with toxicity. There have been reports of accidental overdose of timolol, resulting in symptoms of general poisoning similar to those seen with systemic beta-blockers, such as dizziness, headache, shortness of breath (shortness of breath), bradycardia, bronchospasm, and cardiac arrest (see. (See also section "Adverse Reactions"). If an overdose of Tapticom® occurs, treatment should be symptomatic and supportive. Timolol is not actively removed by hemodialysis.

  • Brand name: Taptiqom

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