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Mycamine

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Overview

What is Mycamine?

MYCAMINE is a sterile, lyophilized product for intravenous (IV) infusion that contains micafungin sodium. Micafungin sodium is a semisynthetic lipopeptide (echinocandin) synthesized by a chemical modification of a fermentation product of F-11899. Micafungin inhibits the synthesis of 1, 3-beta-D-glucan, an integral component of the fungal cell wall.

Each single-dose vial contains 50 mg micafungin (equivalent to 50.86 mg micafungin sodium) or 100 mg micafungin (equivalent to 101.73 mg micafungin sodium), 200 mg lactose, with citric acid and/or sodium hydroxide (used for pH adjustment). MYCAMINE must be diluted with 0.9% Sodium Chloride Injection, USP, or 5% Dextrose Injection, USP . Following reconstitution with 0.9% Sodium Chloride Injection, USP, the resulting pH of the solution is between 5-7.

Micafungin sodium is chemically designated as:

Pneumocandin A0,1-[(4,5)-4,5-dihydroxy- -[4-[5-[4-(pentyloxy)phenyl]-3-isoxazolyl]benzoyl]-L-ornithine]-4-[(4)-4-hydroxy-4-[4-hydroxy-3-(sulfooxy)phenyl]-L-threonine]-, monosodium salt.

The chemical structure of micafungin sodium is:

The empirical/molecular formula is CHNNaOS and the formula weight is 1292.26.

Micafungin sodium is a light-sensitive, hygroscopic white powder that is freely soluble in water, isotonic sodium chloride solution, N,N-dimethylformamide and dimethylsulfoxide, slightly soluble in methyl alcohol, and practically insoluble in acetonitrile, ethyl alcohol (95%), acetone, diethyl ether and n-hexane.



What does Mycamine look like?



What are the available doses of Mycamine?

MYCAMINE (micafungin) for injection is supplied in a single-dose vial containing 50 mg micafungin, equivalent to 50.86 mg micafungin sodium ()

MYCAMINE (micafungin) for injection is supplied in a single-dose vial containing 100 mg micafungin, equivalent to 101.73 mg micafungin sodium ()

What should I talk to my health care provider before I take Mycamine?

How should I use Mycamine?

MYCAMINE is indicated in adult and pediatric patients 4 months and older for:

Do not mix or co-infuse MYCAMINE with other medications. MYCAMINE has been shown to precipitate when mixed directly with a number of other commonly used medications.The recommended doses for adult patients based on indications are shown in .


What interacts with Mycamine?

Sorry No Records found


What are the warnings of Mycamine?

Sorry No Records found


What are the precautions of Mycamine?

Sorry No Records found


What are the side effects of Mycamine?

Sorry No records found


What should I look out for while using Mycamine?

MYCAMINE is contraindicated in persons with known hypersensitivity to micafungin, any component of MYCAMINE, or other echinocandins.


What might happen if I take too much Mycamine?

MYCAMINE is highly protein bound and, therefore, is not dialyzable. No cases of MYCAMINE overdosage have been reported. Repeated daily doses up to 8 mg/kg (maximum total dose of 896 mg) in adult patients, up to 6 mg/kg in pediatric patients 4 months of age and older, and up to 10 mg/kg in pediatric patients less than 4 months of age have been administered in clinical trials with no reported dose-limiting toxicity. The minimum lethal dose of MYCAMINE is 125 mg/kg in rats, equivalent to 8 times the recommended highest adult clinical dose (150 mg) and approximately 7 times the highest pediatric clinical dose (3 mg/kg), based on body surface area comparisons. 


How should I store and handle Mycamine?

HICON should be stored between 2°C and 25°C (36°F and 77°F). Store and dispose of HICON in compliance with the appropriate regulations of the government agency authorized to license the use of this radionuclide.Discard unused capsules after all HICON solution has been dispensed or expired. New blister packages of hard gelatin capsules are provided with each new shipment of HICON.This radiopharmaceutical is approved for use by persons under license by the Nuclear Regulatory Commission or the relevant regulatory authority of an Agreement State.HICON should be stored between 2°C and 25°C (36°F and 77°F). Store and dispose of HICON in compliance with the appropriate regulations of the government agency authorized to license the use of this radionuclide.Discard unused capsules after all HICON solution has been dispensed or expired. New blister packages of hard gelatin capsules are provided with each new shipment of HICON.This radiopharmaceutical is approved for use by persons under license by the Nuclear Regulatory Commission or the relevant regulatory authority of an Agreement State.HICON should be stored between 2°C and 25°C (36°F and 77°F). Store and dispose of HICON in compliance with the appropriate regulations of the government agency authorized to license the use of this radionuclide.Discard unused capsules after all HICON solution has been dispensed or expired. New blister packages of hard gelatin capsules are provided with each new shipment of HICON.This radiopharmaceutical is approved for use by persons under license by the Nuclear Regulatory Commission or the relevant regulatory authority of an Agreement State.MYCAMINE is available in:StorageUnopened vials of lyophilized material must be stored at room temperature, 25°C (77°F); excursions permitted to 15°-30°C (59°- 86°F) The reconstituted product may be stored in the original vial for up to 24 hours at room temperature, 25°C (77°F). The diluted infusion should be protected from light and may be stored for up to 24 hours at room temperature, 25°C (77°F). MYCAMINE is available in:StorageUnopened vials of lyophilized material must be stored at room temperature, 25°C (77°F); excursions permitted to 15°-30°C (59°- 86°F) The reconstituted product may be stored in the original vial for up to 24 hours at room temperature, 25°C (77°F). The diluted infusion should be protected from light and may be stored for up to 24 hours at room temperature, 25°C (77°F). MYCAMINE is available in:StorageUnopened vials of lyophilized material must be stored at room temperature, 25°C (77°F); excursions permitted to 15°-30°C (59°- 86°F) The reconstituted product may be stored in the original vial for up to 24 hours at room temperature, 25°C (77°F). The diluted infusion should be protected from light and may be stored for up to 24 hours at room temperature, 25°C (77°F). MYCAMINE is available in:StorageUnopened vials of lyophilized material must be stored at room temperature, 25°C (77°F); excursions permitted to 15°-30°C (59°- 86°F) The reconstituted product may be stored in the original vial for up to 24 hours at room temperature, 25°C (77°F). The diluted infusion should be protected from light and may be stored for up to 24 hours at room temperature, 25°C (77°F). MYCAMINE is available in:StorageUnopened vials of lyophilized material must be stored at room temperature, 25°C (77°F); excursions permitted to 15°-30°C (59°- 86°F) The reconstituted product may be stored in the original vial for up to 24 hours at room temperature, 25°C (77°F). The diluted infusion should be protected from light and may be stored for up to 24 hours at room temperature, 25°C (77°F).


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Clinical Information

Chemical Structure

No Image found
Clinical Pharmacology

Micafungin is a member of the echinocandin class of antifungal agents .

Non-Clinical Toxicology
MYCAMINE is contraindicated in persons with known hypersensitivity to micafungin, any component of MYCAMINE, or other echinocandins.

Bisoprolol fumarate and hydrochlorothiazide may potentiate the action of other antihypertensive agents used concomitantly. Bisoprolol fumarate and hydrochlorothiazide should not be combined with other beta-blocking agents. Patients receiving catecholamine-depleting drugs, such as reserpine or guanethidine, should be closely monitored because the added beta-adrenergic blocking action of bisoprolol fumarate may produce excessive reduction of sympathetic activity. In patients receiving concurrent therapy with clonidine, if therapy is to be discontinued, it is suggested that bisoprolol fumarate and hydrochlorothiazide be discontinued for several days before the withdrawal of clonidine.

Bisoprolol fumarate and hydrochlorothiazide should be used with caution when myocardial depressants or inhibitors of AV conduction, such as certain calcium antagonists (particularly of the phenylalkylamine [verapamil] and benzothiazepine [diltiazem] classes), or antiarrhythmic agents, such as disopyramide, are used concurrently.

Both digitalis glycosides and beta-blockers slow atrioventricular conduction and decrease heart rate. Concomitant use can increase the risk of bradycardia.

Isolated cases of serious hypersensitivity (anaphylaxis and anaphylactoid) reactions (including shock) have been reported in patients receiving MYCAMINE. If these reactions occur, MYCAMINE infusion should be discontinued and appropriate treatment administered.

The overall safety of MYCAMINE was assessed in 3227 adult and pediatric patients and 520 volunteers in 46 clinical trials, including the invasive candidiasis, esophageal candidiasis and prophylaxis trials, who received single or multiple doses of MYCAMINE, ranging from 0.75 mg/kg to 10 mg/kg in pediatric patients and 12.5 mg to 150 mg/day or greater in adult patients.

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in clinical trials of MYCAMINE cannot be directly compared to rates in clinical trials of another drug and may not reflect the rates observed in practice. The adverse reaction information from clinical trials does provide a basis for identifying adverse events that appear to be related to drug use and for approximating rates.

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Reference

This information is obtained from the National Institute of Health's Standard Packaging Label drug database.
"https://dailymed.nlm.nih.gov/dailymed/"

While we update our database periodically, we cannot guarantee it is always updated to the latest version.

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Professional

Clonazepam Description Each single-scored tablet, for oral administration, contains 0.5 mg, 1 mg, or 2 mg Clonazepam, USP, a benzodiazepine. Each tablet also contains corn starch, lactose monohydrate, magnesium stearate, microcrystalline cellulose, and povidone. Clonazepam tablets USP 0.5 mg contain Yellow D&C No. 10 Aluminum Lake. Clonazepam tablets USP 1 mg contain Yellow D&C No. 10 Aluminum Lake, as well as FD&C Blue No. 1 Aluminum Lake. Chemically, Clonazepam, USP is 5-(o-chlorophenyl)-1,3-dihydro-7-nitro-2H-1,4-benzodiazepin-2-one. It is a light yellow crystalline powder. It has the following structural formula: C15H10ClN3O3 M.W. 315.72
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Tips

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Interactions

Interactions

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