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Mikelan

Name: Mikelan drug & pharmaceuticals. Mikelan available forms, doses, prices
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Published: 2021-11-11T10:10:10+00:00

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Mikelan^®

(carteolol HCl ophthalmic solution)1% STERILE

Mikelan^® (carteolol hydrochloride ophthalmic solution), 1%, is a nonselective beta-adrenoceptor blocking agent for ophthalmic use.

The chemical name for Mikelan is (±)–5–[3–[(1,1–dimethylethyl) amino]–2 hydroxypropoxy]–3, 4–dihydro–2(1H)–quinolinone monohydrochloride. The structural formula is as follows:Each mL contains 10 mg carteolol HCl and the inactive ingredients – Benzalkonium chloride 0.05 mg (0.005%) as a preservative; sodium chloride; sodium phosphate, dibasic; sodium phosphate, monobasic; and water for injection, USP. The product has a pH of 6.2 to 7.2CLINICAL PHARMACOLOGY

Carteolol HCl is a nonselective beta-adrenergic blocking agent with associated intrinsic sympathomimetic activity and without significant membrane-stabilizing activity.

Mikelan (carteolol HCl) reduces normal and elevated intraocular pressure (IOP) whether or not accompanied by glaucoma. The exact mechanism of the ocular hypotensive effect of beta-blockers has not been definitely demonstrated. In general, beta-adrenergic blockers reduce cardiac output in patients in good and poor cardiovascular health. In patients with severe impairment of myocardial function, beta-blockers may inhibit the sympathetic stimulation necessary to maintain adequate cardiac function. Beta-adrenergic blockers may also increase airway resistance in the bronchi and bronchioles due to unopposed parasympathetic activity. Given topically twice daily in controlled domestic clinical trials ranging from 1.5 to 3 months, Mikelan produced a median percent reduction of IOP 22% to 25%. No significant effects were noted on corneal sensitivity, tear secretion, or pupil size.INDICATIONS AND USAGE

Mikelan Ophthalmic Solution, 1%, has been shown to be effective in lowering intraocular pressure and may be used in patients with chronic open-angle glaucoma and intraocular hypertension. It may be used alone or in combination with other intraocular pressure lowering medications.

CONTRAINDICATIONS

Mikelan Ophthalmic Solution is contraindicated in those individuals with bronchial asthma or with a history of bronchial asthma, or severe chronic obstructive pulmonary disease ; sinus bradycardia; second- and third-degree atrioventricular block; overt cardiac failure ; cardiogenic shock; or hypersensitivity to any component of this product.

WARNINGS

Mikelan Ophthalmic Solution has not been detected in plasma following ocular instillation. However, as with other topically applied ophthalmic preparations, Mikelan may be absorbed systemically. The same adverse reactions found with systemic administration of beta-adrenergic blocking agents may occur with topical administration. For example, severe respiratory reactions and cardiac reactions, including death due to bronchospasm in patients with asthma, and rarely death in association with cardiac failure, have been reported with topical application of beta-adrenergic blocking agents.

Cardiac Failure

Sympathetic stimulation may be essential for support of the circulation in individuals with diminished myocardial contractility, and its inhibition by beta-adrenergic receptor blockade may precipitate more severe failure.

In Patients Without a History of Cardiac Failure

Continued depression of the myocardium with beta-blocking agents over a period of time can, in some cases, lead to cardiac failure. At the first sign or symptom of cardiac failure, Mikelan should be discontinued.

Non-allergic Bronchospasm

In patients with non-allergic bronchospasm or with a history of non-allergic bronchospasm (e.g., chronic bronchitis, emphysema), Mikelan should be administered with caution since it may block bronchodilation produced by endogenous and exogenous catecholamine stimulation of beta₂ receptors.

Major Surgery

The necessity or desirability of withdrawal of beta-adrenergic blocking agents prior to major surgery is controversial. Beta-adrenergic receptor blockade impairs the ability of the heart to respond to beta-adrenergically mediated reflex stimuli. This may augment the risk of general anesthesia in surgical procedures. Some patients receiving beta-adrenergic receptor blocking agents have been subject to protracted severe hypotension during anesthesia. For these reasons, in patients undergoing elective surgery, gradual withdrawal of beta-adrenergic receptor blocking agents may be appropriate.

If necessary during surgery, the effects of beta-adrenergic blocking agents may be reversed by sufficient doses of such agonists as isoproterenol, dopamine, dobutamine or levarterenol.Diabetes Mellitus

Beta-adrenergic blocking agents should be administered with caution in patients subject to spontaneous hypoglycemia or to diabetic patients (especially those with labile diabetes) who are receiving insulin or oral hypoglycemic agents. Beta-adrenergic receptor blocking agents may mask the signs and symptoms of acute hypoglycemia.

Thyrotoxicosis

Beta-adrenergic blocking agents may mask certain clinical signs (e.g., tachycardia) of hyperthyroidism. Patients suspected of developing thyrotoxicosis should be managed carefully to avoid abrupt withdrawal of beta-adrenergic blocking agents which might precipitate a thyroid storm.

PRECAUTIONSGeneral

Mikelan Ophthalmic Solution should be used with caution in patients with known hypersensitivity to other beta-adrenoceptor blocking agents.

Use with caution in patients with known diminished pulmonary function. In patients with angle-closure glaucoma, the immediate objective of treatment is to reopen the angle. This requires constricting the pupil with a miotic. Mikelan has little or no effect on the pupil. When Mikelan is used to reduce elevated intraocular pressure in angle-closure glaucoma, it should be used with a miotic and not alone.Information to the Patient

For topical use only. To prevent contaminating the dropper tip and solution, care should be taken not to touch the eyelids or surrounding areas with the dropper tip of the bottle. Keep bottle tightly closed when not in use. Protect from light.

Risk from Anaphylactic Reaction

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 accidental, diagnostic, or therapeutic challenge with such allergens. Such patients may be unresponsive to the usual doses of epinephrine used to treat anaphylactic reactions.

Muscle Weakness

Beta-adrenergic blockade has been reported to potentiate muscle weakness consistent with certain myasthenic symptoms (e.g., diplopia, ptosis and generalized weakness).

Drug Interactions

Mikelan should be used with caution in patients who are receiving a beta-adrenergic blocking agent orally, because of the potential for additive effects on systemic beta-blockade.

Close observation of the patient is recommended when a beta-blocker is administered to patients receiving catecholamine-depleting drugs such as reserpine, because of possible additive effects and the production of hypotension and/or marked bradycardia, which may produce vertigo, syncope, or postural hypotension.Carcinogenesis, Mutagenesis, Impairment of Fertility

Mikelan did not produce carcinogenic effects at doses up to 40 mg/kg/day in two-year oral rat and mouse studies. Tests of mutagenicity, including the Ames Test, recombinant (rec)-assay, in vivo cytogenetics and dominant lethal assay demonstrated no evidence for mutagenic potential. Fertility of male and female rats and male and female mice was unaffected by administration of Mikelan dosages up to 150 mg/kg/day.

PregnancyTeratogenic EffectsPregnancy Category C

Mikelan increased resorptions and decreased fetal weights in rabbits and rats at maternally toxic doses approximately 1052 and 5264 times the maximum recommended human oral dose (10 mg/70 kg/day), respectively. A dose-related increase in wavy ribs was noted in the developing rat fetus when pregnant females received daily doses of approximately 212 times the maximum recommended human oral dose. No such effects were noted in pregnant mice subjected to up to 1052 times the maximum recommended human oral dose. There are no adequate and well-controlled studies in pregnant women. Mikelan (carteolol hydrochloride) should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

Nursing Mothers

It is not known whether this drug is excreted in human milk, although in animal studies carteolol has been shown to be excreted in breast milk. Caution should be exercised when Mikelan is administered to nursing mothers.

Pediatric Use

Safety and effectiveness in pediatric patients have not been established.

ADVERSE REACTIONS

The following adverse reactions have been reported in clinical trials with Mikelan Ophthalmic Solution:

Ocular

Transient eye irritation, burning, tearing, conjunctival hyperemia and edema occurred in about 1 of 4 patients. Ocular symptoms including blurred and cloudy vision, photophobia, decreased night vision, and ptosis and ocular signs including blepharoconjunctivitis, abnormal corneal staining, and corneal sensitivity occurred occasionally.

Systemic

As is characteristic of nonselective adrenergic blocking agents, Mikelan may cause bradycardia and decreased blood pressure. The following systemic events have occasionally been reported with the use of Mikelan: cardiac arrhythmia, heart palpitation, dyspnea, asthenia, headache, dizziness, insomnia, sinusitis, and taste perversion.

The following additional adverse reactions have been reported with ophthalmic use of beta₁ and beta₂ (nonselective) adrenergic receptor blocking agents:Body As a Whole: HeadacheCardiovascular: Arrhythmia, syncope, heart block, cerebral vascular accident, cerebral ischemia, congestive heart failure, palpitation.Digestive: NauseaPsychiatric: DepressionSkin: Hypersensitivity, including localized and generalized rashRespiratory: Bronchospasm (predominantly in patients with pre-existing bronchospastic disease), respiratory failure Endocrine: Masked symptoms of hypoglycemia in insulin-dependent diabetics Special Senses: Signs and symptoms of keratitis, blepharoptosis, visual disturbances including refractive changes (due to withdrawal of miotic therapy in some cases), diplopia, ptosis. Other reactions associated with the oral use of nonselective adrenergic receptor blocking agents should be considered potential effects with ophthalmic use of these agents.OVERDOSAGE

No specific information on emergency treatment of overdosage in humans is available. Should accidental ocular overdosage occur, flush eye(s) with water or normal saline. The most common effects expected with overdosage of a beta-adrenergic blocking agent are bradycardia, bronchospasm, congestive heart failure and hypotension.

In case of ingestion, treatment with Mikelan should be discontinued and gastric lavage considered. The patient should be closely observed and vital signs carefully monitored. The prolonged effects of carteolol must be considered when determining the duration of corrective therapy. On the basis of the pharmacologic profile, the following additional measures should be considered as appropriate:Symptomatic Sinus Bradycardia or Heart Block: Administer atropine. If there is no response to vagal blockade, administer isoproterenol cautiously.Bronchospasm: Administer a beta₂-stimulating agent such as isoproterenol and/or a theophylline derivative.Congestive Heart Failure: Administer diuretics and digitalis glycosides as necessary.Hypotension: Administer vasopressors such as intravenous dopamine, epinephrine or norepinephrine bitartrate.DOSAGE AND ADMINISTRATION

The usual dose is one drop of Mikelan Ophthalmic Solution, 1%, in the affected eye(s) twice a day.

If the patient’s IOP is not at a satisfactory level on this regimen, concomitant therapy with pilocarpine and other miotics, and/or epinephrine or dipivefrin, and/or systemically administered carbonic anhydrase inhibitors, such as acetazolamide, can be instituted.HOW SUPPLIED

Mikelan Ophthalmic Solution, 1%, is supplied as a sterile ophthalmic solution in plastic dispenser bottles of 5 mL (NDC 58768-001-01), 10 mL (NDC 58768-001-02) and 15 mL (NDC 58768-001-04).

Store at 15° to 25°C (59° to 77°F) (room temperature) and protect from light.Rx OnlyLicensed under U.S. Patent Nos. 3910924 and 4309432.Made in Canada by:CIBA Vision Sterile Mfg.,Mississauga, Ontario L5N 2X5For: Novartis Ophthalmics, Duluth, Georgia 30097I6138-B

Mikelan pharmaceutical active ingredients containing related brand and generic drugs:

Carteolol Hydrochloride

Mikelan available forms, composition, doses:

Tablets; Oral; Carteolol Hydrochloride 20 mg
Tablets; Oral; Carteolol Hydrochloride 5 mg

Mikelan destination | category:

Human:
Beta-blockers

Mikelan Anatomical Therapeutic Chemical codes:

C07AA15 - Carteolol

Mikelan pharmaceutical companies:

References

Dailymed."OCUPRESS (CARTEOLOL HYDROCHLORIDE) SOLUTION [NOVARTIS OPHTHALMICS]". https://dailymed.nlm.nih.gov/dailym... (accessed August 28, 2018).
"CARTEOLOL". https://pubchem.ncbi.nlm.nih.gov/co... (accessed August 28, 2018).
"CARTEOLOL". http://www.drugbank.ca/drugs/DB0052... (accessed August 28, 2018).

Frequently asked Questions

Can i drive or operate heavy machine after consuming Mikelan?

Depending on the reaction of the Mikelan after taken, if you are feeling dizziness, drowsiness or any weakness as a reaction on your body, Then consider Mikelan not safe to drive or operate heavy machine after consumption. Meaning that, do not drive or operate heavy duty machines after taking the capsule if the capsule has a strange reaction on your body like dizziness, drowsiness. As prescribed by a pharmacist, it is dangerous to take alcohol while taking medicines as it exposed patients to drowsiness and health risk. Please take note of such effect most especially when taking Primosa capsule. It's advisable to consult your doctor on time for a proper recommendation and medical consultations.

Is Mikelan addictive or habit forming?

Medicines are not designed with the mind of creating an addiction or abuse on the health of the users. Addictive Medicine is categorically called Controlled substances by the government. For instance, Schedule H or X in India and schedule II-V in the US are controlled substances.

Please consult the medicine instruction manual on how to use and ensure it is not a controlled substance.In conclusion, self medication is a killer to your health. Consult your doctor for a proper prescription, recommendation, and guidiance.

Review

sdrugs.com conducted a study on Mikelan, and the result of the survey is set out below. It is noteworthy that the product of the survey is based on the perception and impressions of the visitors of the website as well as the views of Mikelan consumers. We, as a result of this, advice that you do not base your therapeutic or medical decisions on this result, but rather consult your certified medical experts for their recommendations.