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Macrilen

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Overview

What is Macrilen?

MACRILEN for oral solution is macimorelin acetate, a synthetic growth hormone secretagogue receptor agonist. Macimorelin acetate is described chemically as D-Tryptophanamide, 2-methylalanyl-N-[(1R)-1-(formylamino)-2-(1H-indol-3-yl)ethyl]-acetate.

The molecular formula for macimorelin acetate is CHNO with a molecular weight of 534.6 g/mol.

Figure 1: Chemical structure of macimorelin acetate

Each aluminum pouch of MACRILEN contains 60 mg of macimorelin, equivalent to 68 mg of macimorelin acetate, and the following inactive ingredients: lactose monohydrate, crospovidone, sodium stearyl fumarate, saccharin sodium and colloidal silicon dioxide.



What does Macrilen look like?



What are the available doses of Macrilen?

For oral solution: 60 mg ()

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

How should I use Macrilen?

MACRILEN is indicated for the diagnosis of adult growth hormone deficiency (AGHD).

The recommended dose is a single oral dose of 0.5 mg/kg of macimorelin. The dose is administered as a reconstituted solution in patients fasted for at least 8 hours.


What interacts with Macrilen?

Sorry No Records found


What are the warnings of Macrilen?

Sorry No Records found


What are the precautions of Macrilen?

Sorry No Records found


What are the side effects of Macrilen?

Sorry No records found


What should I look out for while using Macrilen?

None


What might happen if I take too much Macrilen?

In the event of an overdose, symptomatic and supportive measures should be employed.


How should I store and handle Macrilen?

Store olanzapine orally disintegrating tablets at controlled room temperature, 20° to 25°C (68° to 77°F) [ USP]. The USP defines controlled room temperature as a temperature maintained thermostatically that encompasses the usual and customary working environment of 20° to 25°C (68° to 77°F); that results in a mean kinetic temperature calculated to be not more than 25°C; and that allows for excursions between 15° and 30°C (59° and 86°F) that are experienced in pharmacies, hospitals, and warehouses.Protect olanzapine orally disintegrating tablets from light and moisture.Store olanzapine orally disintegrating tablets at controlled room temperature, 20° to 25°C (68° to 77°F) [ USP]. The USP defines controlled room temperature as a temperature maintained thermostatically that encompasses the usual and customary working environment of 20° to 25°C (68° to 77°F); that results in a mean kinetic temperature calculated to be not more than 25°C; and that allows for excursions between 15° and 30°C (59° and 86°F) that are experienced in pharmacies, hospitals, and warehouses.Protect olanzapine orally disintegrating tablets from light and moisture.Store olanzapine orally disintegrating tablets at controlled room temperature, 20° to 25°C (68° to 77°F) [ USP]. The USP defines controlled room temperature as a temperature maintained thermostatically that encompasses the usual and customary working environment of 20° to 25°C (68° to 77°F); that results in a mean kinetic temperature calculated to be not more than 25°C; and that allows for excursions between 15° and 30°C (59° and 86°F) that are experienced in pharmacies, hospitals, and warehouses.Protect olanzapine orally disintegrating tablets from light and moisture.MACRILEN 60 mg is supplied as white to off-white granules in an aluminum pouch. Each pouch contains 60 mg macimorelin (equivalent to 68 mg macimorelin acetate) that when reconstituted with 120 mL of water provides a 60 mg/120 mL (0.5 mg/mL) macimorelin solution.MACRILEN is available in boxes containing 1 pouch per box (NDC 71090-002-02).Before administration, MACRILEN for oral solution must be reconstituted by a healthcare professional Store pouches under refrigeration at 2-8°C (36-46°F).The solution must be used within 30 minutes after preparation. Discard unused portion.MACRILEN 60 mg is supplied as white to off-white granules in an aluminum pouch. Each pouch contains 60 mg macimorelin (equivalent to 68 mg macimorelin acetate) that when reconstituted with 120 mL of water provides a 60 mg/120 mL (0.5 mg/mL) macimorelin solution.MACRILEN is available in boxes containing 1 pouch per box (NDC 71090-002-02).Before administration, MACRILEN for oral solution must be reconstituted by a healthcare professional Store pouches under refrigeration at 2-8°C (36-46°F).The solution must be used within 30 minutes after preparation. Discard unused portion.MACRILEN 60 mg is supplied as white to off-white granules in an aluminum pouch. Each pouch contains 60 mg macimorelin (equivalent to 68 mg macimorelin acetate) that when reconstituted with 120 mL of water provides a 60 mg/120 mL (0.5 mg/mL) macimorelin solution.MACRILEN is available in boxes containing 1 pouch per box (NDC 71090-002-02).Before administration, MACRILEN for oral solution must be reconstituted by a healthcare professional Store pouches under refrigeration at 2-8°C (36-46°F).The solution must be used within 30 minutes after preparation. Discard unused portion.MACRILEN 60 mg is supplied as white to off-white granules in an aluminum pouch. Each pouch contains 60 mg macimorelin (equivalent to 68 mg macimorelin acetate) that when reconstituted with 120 mL of water provides a 60 mg/120 mL (0.5 mg/mL) macimorelin solution.MACRILEN is available in boxes containing 1 pouch per box (NDC 71090-002-02).Before administration, MACRILEN for oral solution must be reconstituted by a healthcare professional Store pouches under refrigeration at 2-8°C (36-46°F).The solution must be used within 30 minutes after preparation. Discard unused portion.MACRILEN 60 mg is supplied as white to off-white granules in an aluminum pouch. Each pouch contains 60 mg macimorelin (equivalent to 68 mg macimorelin acetate) that when reconstituted with 120 mL of water provides a 60 mg/120 mL (0.5 mg/mL) macimorelin solution.MACRILEN is available in boxes containing 1 pouch per box (NDC 71090-002-02).Before administration, MACRILEN for oral solution must be reconstituted by a healthcare professional Store pouches under refrigeration at 2-8°C (36-46°F).The solution must be used within 30 minutes after preparation. Discard unused portion.


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Clinical Information

Chemical Structure

No Image found
Clinical Pharmacology

Macimorelin stimulates GH release by activating growth hormone secretagogue receptors present in the pituitary and hypothalamus.

Non-Clinical Toxicology
None

Most reports of clinically significant drug interactions occurring with the barbiturates have involved phenobarbital. However, the application of these data to other barbiturates appears valid and warrants serial blood level determinations of the relevant drugs when there are multiple therapies.

MACRILEN causes an increase of about 11 msec in the corrected QT (QTc) interval . QT prolongation can lead to development of torsade de pointes-type ventricular tachycardia with the risk increasing as the degree of prolongation increases. The concomitant use of MACRILEN with drugs that are known to prolong the QT interval should be avoided .

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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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Interactions

Interactions

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