Aveeno Hydrocortisone Anti Itch
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Questions & Answers
Side Effects & Adverse Reactions
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Manufacturer Warnings
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FDA Labeling Changes
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Uses
MOVANTIK (naloxegol) is indicated for the treatment of opioid-induced constipation (OIC) in adult patients with chronic non-cancer pain.
History
There is currently no drug history available for this drug.
Other Information
MOVANTIK (naloxegol), an opioid antagonist, contains naloxegol oxalate as the active ingredient. (Naloxegol is a PEGylated derivative of naloxone.)
The chemical name for naloxegol oxalate is: (5α,6α)-17-allyl-6-(2,5,8,11,14,17,20-heptaoxadocosan-22-yloxy)-4,5-epoxymorphinan-3,14-diol oxalate. The structural formula is:
The empirical formula for naloxegol oxalate is C34H53NO11.C2H2O4 and the molecular weight is 742.
Naloxegol oxalate is a white to off-white powder, with high aqueous solubility across the physiologic pH range.
MOVANTIK (naloxegol) tablets for oral use contain 14.2 mg and 28.5 mg of naloxegol oxalate, respectively equivalent to 12.5 mg and 25 mg of naloxegol.
Excipients in tablet core are: mannitol, cellulose microcrystalline, croscarmellose sodium, magnesium stearate, and propyl gallate.
Excipients in tablet coat are: hypromellose, titanium dioxide, polyethylene glycol, iron oxide red, and iron oxide black.
Sources
Aveeno Hydrocortisone Anti Itch Manufacturers
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Johnson & Johnson Consumer Products Company, Division Of Johnson & Johnson Consumer Companies, Inc.
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Aveeno Hydrocortisone Anti Itch | Astrazeneca Pharmaceuticals Lp
2.1 Administration • Discontinue all maintenance laxative therapy prior to initiation of MOVANTIK. Laxative(s) can be used as needed if there is a suboptimal response to MOVANTIK after three days. • Alteration in analgesic dosing regimen prior to initiating MOVANTIK is not required. • MOVANTIK has been shown to be efficacious in patients who have taken opioids for at least 4 weeks. Sustained exposure to opioids prior to starting MOVANTIK may increase the patient's sensitivity to the effects of MOVANTIK [ see Clinical Studies (14)]. • Take MOVANTIK on an empty stomach at least 1 hour prior to the first meal of the day or 2 hours after the meal. • Swallow tablets whole, do not crush or chew. • Avoid consumption of grapefruit or grapefruit juice during treatment with MOVANTIK. • Discontinue MOVANTIK if treatment with the opioid pain medication is also discontinued. 2.2 Adult DosageThe recommended MOVANTIK dosage is 25 mg once daily in the morning.
If patients are not able to tolerate MOVANTIK, reduce the dosage to 12.5 mg once daily [see Clinical Pharmacology (12.2)].
2.3 Dosage in Adult Patients with Renal ImpairmentThe starting dosage for patients with creatinine clearance (CLcr) < 60 mL/min (i.e., patients with moderate, severe or end-stage renal impairment) is 12.5 mg once daily. If this dosage is well tolerated but OIC symptoms continue, the dosage may be increased to 25 mg once daily taking into consideration the potential for markedly increased exposures in some patients with renal impairment and the increased risk of adverse reactions with higher exposures [see Use in Specific Populations (8.6) and Clinical Pharmacology (12.3)].
2.4 Dosage Recommendations due to Drug InteractionsAvoid concomitant use of MOVANTIK with moderate CYP3A4 inhibitor drugs (e.g., diltiazem, erythromycin, verapamil). If concurrent use is unavoidable, reduce the MOVANTIK dosage to 12.5 mg once daily and monitor for adverse reactions [see Drug Interactions (7.1) and Clinical Pharmacology (12.3)].
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