INTRACAMERAL INJECTION
Mydriocain PT
Mydriocain PT
Phenylephrine, Tropicamide And Lidocaine Injection
THIS LEAFLET CONTAINS IMPORTANT PRODUCT USE AND SAFETY INFORMATION, PLEASE READ CAREFULLY AND RETAIN FOR FURTHER FUTURE REFERENCE.
DESCRIPTION:
Mydriocain PT Injection is a solution which is injected into the eye. it contains three active substances:
-Tropicamide which belongs to a group of medicines blocking the passage of impulses through particular nerves (known as anticholinergics),
-Phenylephrine Hydrochloride Which belongs to a group of medicines mimicking the effects of impulses conveyed through particular nerves (known as alpha sympathomimetics).Lidocaine Hydrochloride which belongs to a class of drugs called amide type local anesthetics.
COMPOSITION:
Each ML Contains:
● Phenylephrine Hydrochloride..........USP........... 0.31% w/v
● Tropicamide..........USP...........0.02% w/v
● Lidocaine Hydrochloride..........USP...........1% w/v
● Lidocaine Hydrochloride..........USP...........1% w/v
INDICATION
Mydriocain PT Injection is used in adults only. It will be administered by ophthalmic surgeon by injection into the eye at the beginning of cataract surgery (cloudiness of the lens), in order to enlarge the pupil of your eye (mydriasis) and to obtain anaesthesia in your eye during the surgical procedure.
CLINICAL PHARMACOLOGY
A) Pharmacodynamic Properties
Mydriocain PT Injection is a solution for intracameral injection which combines two synthetic mydriatic agents (Tropicamide - anticholinergic, and Phenylephrine Hydrochloride - alpha sympathomimetic) and one local anaesthetic (Lidocaine Hydrochloride).
B) Mechanism Of Action
Phenylephrine is a direct acting sympathomimetic agent. It causes mydriasis via the stimulation of alpha-adrenergic receptors of the pupillary dilator (the resulting contraction of the pupillary dilator causes pupil dilation). There is almost no cycloplegic effect. Tropicamide is a para sympatholytic agent, which acts by binding to and blocking the M4 muscarinic receptors of the eye muscles. It prevents the iris sphincter muscle and ciliary body muscle from responding to cholinergic stimulation, producing dilation of the pupil and paralysis of the ciliary muscle (cyclopegia).Lidocaine Hydrochloride is a local anaesthetic of the amide type. It acts by inhibiting the ionic refluxes required for the initiation and conduction of impulses, thereby stabilising the neuronal membrane.
C) Pharmacodynamic Effects
Although Tropicamide as a mono therapy produces both mydriasis and cycloplegia, additional mydriasis occurs if sympathomimetic agents such as phenylephrine are used simultaneously. Such synergistic combinations are commonly prescribed to achieve maximal dilation of the pupil for cataract extraction. As an average, 95% of the dilation measured before the viscoelastic injection was obtained within 30 seconds after a single 200-uL.
DOSE AND ADMINISTRATION
Mydriocain PT Injection will be administered by an ophthalmic surgeon, under local anesthesia, at the beginning of cataracts urgery. The recommended dose is 0.2 ml of solution, in only one injection. No dditional dose should be injected as no additional effect has been shown and as increased loss of endothelial cells (cells of a layer covering the posterior surface of the cornea) has been observed. The same dose is used for both adults and the elderly. The safety and efficacy of Mydriocain PT Injection in children aged 0 to 18 years have not been established.
Method Of Administration
Intracameral use The following procedure should be followed:
1. Five minutes before performing the pre-operative antiseptic procedure and the first incision, one to two drops of anaesthetic eye drops should be instilled in the eye.
2. At the beginning of surgery, 0.2 ml of Mydriocain PT is slowly injected in only one injection by anophthalmic surgeon,via intracameral route, through the side port or principal port.
CONTRAINDICATIONS
- Hypersensitivity to the active substances (Phenylephrine Hydrochloride, Tropicamide and Lidocaine Hydrochloride) or to any of the excipients which is used in formulation of Mydriocain PT Injection.
- Known hypersensitivity to anaesthetics of the amide type.
- Known hypersensitivity to atropine derivatives.
WARNING & PRECAUTION:
Special Warnings
The recommended dose is 0.2 ml of Mydriocain PT Injection; no additional dose should be injected as no significant addon effect has been demonstrated, and as increased endothelial cell loss was observed. Corneal endothelial toxicity has not been reported at the recommended dose of, Mydriocain PT Injection; nevertheless, due to limited data, this risk cannot be excluded.
There is no clinical experience with Mydriocain PT Injection in:
- Insulin-dependent or uncontrolled diabetic patients,
- Patients with corneal disease, especially those with any coexisting endothelial cell impairment,
- Patients with history of uveitis,
- Patients with pupillary abnormalities or presenting an ocular traumatism,
- Patients with very dark irides,
- Cataract surgery when combined with corneal transplantation.
There is no experience in patients at risk of floppy iris syndrome with Mydriocain PT Injection. Such patients should benefit of a step-by-step pupil dilation strategy starting with the administration of mydriatic eye drops. There is no clinical experience during cataract surgery with Mydriocain PT Injection in patients treated with topical mydriatics and for whom pupil constriction (or even miosis) occurs during surgery. Mydriocain PT Injection is not recommended to be used in cataract surgery when combined with vitrectomy, due to the vasoconstricting effects of Phenylephrine.Mydriocain PT Injection is not recommended in subjects with a shallow anterior chamber or a history of acute narrow angle glaucoma.
Special Precautions For Use
Mydriocain PT Injection was shown to produce undetectable or very low systemic concentrations of active substances, Since s ystemic effects of Phenylephrine and Lidocaine are dose dependent, it is unlikely that these effects occur with Mydriocain PT Injection. However, as the risk cannot be excluded, it is reminded that:
- Phenylephrine has sympathomimetic activity that might affect patients in the event of hypertension, cardiac disorders, hyperthyroidism, atherosclerosis or prostate disorders and all subjects presenting with a contraindication to the systemic use of pressor amines;
- Lidocaine should be used with caution in patients with epilepsy, myasthenia gravis, cardiac conduction disturbances, congestive heart failure, bradycardia, severe shock, impaired respiratory function or impaired renal function with a creatinine clearance of less than 10mL/minute.
Interaction With Other Medicinal Products And Other Forms Of Interaction
No interaction studies have been performed with Mydriocain PT Injection.
Since the systemic exposure is expected to be very low, systemic interactions are unlikely.
Fertility, Pregnancy And Lactation
Pregnancy
There are no adequate data from the use of Phenylephrine Hydrochloride and Tropicamide in pregnant women. Animal studies are insufficient with respect to effects on pregnancy, embryonic/foetal development, parturition and postnatal development. Although animal studies have revealed no evidence of harm to the foetus, Lidocaine Hydrochloride crosses the placenta and should not be administered during pregnancy. Even though a negligible systemic uptake is expected, a low systemic exposure cannot be excluded. Therefore, Mydriocain PT Injection should not be used during pregnancy.
Breastfeeding
No data are available concerning the secretion of Phenylephrine Hydrochloride or Tropicamide into breast milk. However, Phenylephrine Hydrochloride is poorly absorbed orally, implying that absorption by the infant would be negligible. On the other hand, infants may be very sensitive to anticholinergics, and despite the expected negligible systemic exposure, tropicamide is there fore not recommended during breast feeding. Small amounts of Lidocaine are secreted into breast milk and there is a possibility of an allergic reaction in the infant. Therefore, Mydriocain PT Injection should not be used during breast feeding.
Fertility
There is no information on whether Mydriocain PT Injection may affect fertility in human males or females.
Effects On Ability To Drive And Use Machines
Mydriocain PT Injection has a moderate influence on the ability to drive and use machines, due to its mydriatic effect. Consequently, after cataract surgery with one Mydriocain PT Injection, the patient should be advised not to drive and/or use machines while the visual disturbances persist.
Overdose
Systemic effects Due to single administration and low expected systemic passage of Mydriocain PT Injection, the risk of systemic effects due to overdose is considered minimal. The symptoms of Phenylephrine Ophthalmic overdose are likely to be effects resulting from systemic absorption, including extreme tiredness, sweating, dizziness, a slow heartbeat, and coma. Because severe toxic reaction to Phenylephrine is of rapid onset and short duration, treatment is primarily supportive. Prompt injection of a rapidly acting alphaadrenergic blocking agent such as Phentolamine (dose 2 to 5 mg in intravenous use) has been recommended. The symptoms of Tropicamide Ophthalmic overdose include headache, fast heartbeat, dry mouth and skin, unusual drowsiness, and flushing. Systemic effects from Tropicamide are not expected. Should an overdose occur causing local effects, e.g. sustained mydriasis, pilocarpine or 0.25% w/v physostigmine should be applied. In the event of excessive absorption of lidocaine into the bloodstream, symptoms may include CNS effects (such as convulsions, unconsciousness and possibly respiratory arrest) and cardiovascular reactions (such as hypotension, myocardial depression, bradycardia and possibly cardiac arrest). Treatment of a patient suffering from systemic toxicity of Lidocaine consists of arresting the convulsions and ensuring adequate ventilation with oxygen, if necessary by assisted or controlled ventilation (respiration).
SHELF LIFE
24 Months.
STORAGE
Store below 30°C, Do not allow to freeze.
HOW SUPPLIED
Mydriocain PT 1 mL Injection is supplied in 2.25 mL Glass Syringe
Moxifur 1ml
MOXIFUR 1ml
Moxifloxacin Ophthalmic Solution USP
THIS LEAFLET CONTAINS IMPORTANT PRODUCT USE AND SAFETY INFORMATION, PLEASE READ CAREFULLY AND RETAIN FOR FURTHER FUTURE REFERENCE.
DESCRIPTION:
Moxifur (Moxifloxacin Ophthalmic Solution USP) is a sterile 1 ml clear, pale yellow coloured, isotonic, preservative free ophthalmic solution.
COMPOSITION:
Each ML Contains:
Moxifloxacin Hydrochloride USP
• Eq. to Moxifloxacin 0.5% w/v
• Aqueous Buffered Vehicle q.s.
INDICATIONS:
Topical treatment of purulent bacterial conjunctivitis, caused by moxifloxacin susceptible strains. Consideration should be given to official guidance on the appropriate use of antibacterial agents.
PHARMACOLOGICAL CLASSIFICATION:
Pharmacotherapeutic group: Ophthalmologicals; anti-infectives, other anti-infectives,
PHARMACODYNAMICS/ PHARMACOKINETICS:
Pharmacodynamics:
Moxifloxacin, a fourth-generation fluoroquinolone, inhibits the DNA gyrase and topoisomerase IV required for bacterial DNA replication, repair, and recombination.
Pharmacokinetics:
Following topical ocular administration of Moxifur (Moxifloxacin Ophthalmic Solution USP), moxifloxacin was absorbed into the systemic circulation. Plasma concentrations of moxifloxacin were measured in 21 male and female subjects who received bilateral topical ocular doses of the medicinal product 3 times a day for 4 days. The mean steady-state Cmax and AUC were 2.7 ng/ml and 41.9 ng· hr/ml, respectively. These exposure values are approximately 1,600 and 1,200 times lower than the mean Cmax and AUC reported after therapeutic 400 mg oral doses of moxifloxacin. The plasma half-life of Moxifloxacin was estimated to be 13 hours.
RECOMMENDED DOSE:
For ocular use only. Not for injection. Moxifur (Moxifloxacin Ophthalmic Solution USP), solution should not be injected subconjunctivally or introduced directly into the anterior chamber of the eye. Use in adults including the elderly (≥ 65 years) The dose is one drop in the affected eye(s) 3 times a day. The infection normally improves within 5 days and treatment should then be continued for a further 2- 3 days. If no improvement is observed within 5 days of initiating therapy, the diagnosis and/or treatment should be reconsidered. The duration of treatment depends on the severity of the disorder and on the clinical and bacteriological course of infection. Paediatric patients. No dosage adjustment is necessary. Use in hepatic and renal impairment No dosage adjustment is necessary. To prevent contamination of the dropper tip and solution, care must be taken not to touch the eyelids, surrounding areas or other surfaces with the dropper tip of the bottle. In order to prevent the drops from being absorbed via the nasal mucosa, particularly in new-born infants or children, the nasolacrimal ducts should be held closed for 2 to 3 minutes with the fingers after administering the drops. After cap is removed, if tamper evident snap collar is loose, remove before using the product. If more than one topical ophthalmic medicinal product is being used, the medicinal products must be administered at least 5 minutes apart. Eye ointments should be administered last.
CONTRA-INDICATIONS:
Hypersensitivity to the active substance, to other quinolones,
WARNING AND PRECAUTION:
In patients receiving systemically administered quinolones, serious and occasionally fatal hypersensitivity (anaphylactic) reactions have been reported, some following the first dose. Some reactions were accompanied by cardiovascular collapse, loss of consciousness, angioedema (including laryngeal, pharyngeal or facial oedema), airway obstruction, dyspnoea, urticaria, and itching.
If an allergic reaction to Moxifur (Moxifloxacin Ophthalmic Solution USP) occurs, discontinue use of the medicinal product. Serious acute hypersensitivity reactions to moxifloxacin or any other product ingredient may require immediate emergency treatment. Oxygen and airway management should be administered where clinically indicated.
As with other anti-infectives, prolonged use may result in overgrowth of non-susceptible organisms, including fungi. If superinfection occurs, discontinue use and institute alternative therapy. Tendon inflammation and rupture may occur with systemic fluoroquinolone therapy including moxifloxacin, particularly in older patients and those treated concurrently with corticosteroids. Following ophthalmic administration of Moxifur (Moxifloxacin Ophthalmic Solution USP) plasma concentrations of moxifloxacin are much lower than after therapeutic oral doses of moxifloxacin, however , caution should be exercised and treatment with Moxifur (Moxifloxacin Ophthalmic Solution USP) should be discontinued at the first sign of tendon inflammation.
Data are very limited to establish efficacy and safety of Moxifur (Moxifloxacin Ophthalmic Solution USP) in the treatment of conjunctivitis in neonates. Therefore use of this medicinal product to treat conjunctivitis in neonates is not recommended.
Moxifur (Moxifloxacin Ophthalmic Solution USP) should not be used for the prophylaxis or empiric treatment of gonococcal conjunctivitis, including gonococcal ophthalmia neonatorum, because of the prevalence of fluoroquinolone-resistant Neisseria gonorrhoeae. Patients with eye infections caused by Neisseria gonorrhoeae should receive appropriate systemic treatment.
The medicinal product is not recommended for the treatment of Chlamydia trachomatis in patients less than 2 years of age as it has not been evaluated in such patients. Patients older than 2 years of age with eye infections caused by Chlamydia trachomitis should receive appropriate systemic treatment.
Neonates with ophthalmia neonatorum should receive appropriate treatment for their condition, e.g. systemic treatment in cases caused by Chlamydia trachomitis or Neisseria gonorrhoeae. Patients should be advised not to wear contact lenses if they have signs and symptoms of a bacterial ocular infection.
INTERACTIONS WITH OTHER MEDICAMENTS:
No specific interaction studies have been performed with Moxifur (Moxifloxacin Ophthalmic Solution USP). Given the low systemic concentration of moxifloxacin following topical ocular administration of the medicinal product, drug interactions are unlikely to occur.
OVERDOSE AND TREATMENT:
The limited holding capacity of the conjunctival sac for ophthalmic products practically precludes any overdosing of the medicinal product. The total amount of moxifloxacin in a single container is too small to induce adverse effects after accidental ingestion.
STORAGE CONDITION:
Preserve in tight containers. Store between 2°C to 25°C.
SHELF LIFE:
24 Months.
HOW SUPPLIED:
Moxifur (Moxifloxacin Ophthalmic Solution USP) 1mL is available in sterile 2ml Glass vial with pouch pack.
APPASAMY ASSOCIATES (P) LTD,No.20, SBI Officer's colony,
1st Street, Arumbakkam, Chennai - 600 106, Tamil Nadu, India.
Call: +91 6382758855 / +91 9381216555
E-mail : info@appasamy.com
©2024 Appasamy Associates Private Limited
.png)
