Maxidex (Dexamethasone Ophthalmic) - Summary

MAXIDEX SUMMARY

MAXIDEX® 0.1% (dexamethasone ophthalmic suspension) is an adrenocortical steroid prepared as a sterile topical ophthalmic suspension.

Maxidex (dexamethasone OPHTHALMIC) is indicated for the following:

Steroid responsive inflammatory conditions of the palpebral and bulbar conjunctiva, cornea, and anterior segment of the globe such as allergic conjunctivitis, acne rosacea, superficial punctuate keratitis, herpes zoster keratitis, iritis, cyclitis, selected infective conjunctivitides when the inherent hazard of steroid use is accepted to obtain an advisable diminution in edema and inflammation; corneal injury from chemical, radiation, or thermal burns, or penetration of foreign bodies.

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NEWS HIGHLIGHTS

Published Studies Related to Maxidex (Dexamethasone Ophthalmic)

Dexamethasone and long-term survival in bacterial meningitis. [2012]
bacterial meningitis are lacking... CONCLUSIONS: In adults with community-acquired bacterial meningitis, the survival

Randomized, double-blind, placebo-controlled, phase III cross-over study evaluating the oral neurokinin-1 antagonist aprepitant in combination with a 5HT3 receptor antagonist and dexamethasone in patients with germ cell tumors receiving 5-day cisplatin combination chemotherapy regimens: a hoosier oncology group study. [2012]
of cisplatin combination chemotherapy for testicular cancer... CONCLUSION: There was a significant improvement in CR rate with aprepitant

Dexamethasone versus ondansetron in combination with dexamethasone for the prophylaxis of postoperative vomiting in pediatric outpatients: a double-blind, randomized, placebo-controlled clinical trial. [2012]
incidence of which ranges from 8.9% to 42%... CONCLUSIONS: The prophylactic use of antiemetic drugs failed to reduce the

Efficacy comparison of periapical infiltration injection of dexamethasone, morphine and placebo for postoperative endodontic pain. [2012]
CONCLUSION: Periapical infiltration of dexamethasone and morphine led to a

Efficacy and safety of dexamethasone ointment on recurrent aphthous ulceration. [2012]
concentrations in the patients... CONCLUSION: Dexamethasone ointment was efficient in the treatment of recurrent

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Clinical Trials Related to Maxidex (Dexamethasone Ophthalmic)

Dexamethasone for Paediatric Adeno-Tonsillectomy - A Dose-Finding Study [Terminated]
Adeno-tonsillectomy is a commonly performed surgical procedure in children. Main morbidities are postoperative pain, nausea and vomiting, and haemorrhage. Non-steroidal anti-inflammatory drugs (NSAIDs)widely used for paincontrol increase the risk of postoperative bleeding and reoperation. Dexamethasone is an powerful antiemetic and has shown analgesic efficacy. Antiemetic and analgesic dose-response has never been established.

XERECEPT® (hCRF) for Patients Requiring Dexamethasone to Treat Edema Associated With Brain Tumors [Completed]
The purpose of this study is to compare the safety and efficacy of XERECEPT® to dexamethasone (Decadron) a common treatment for symptoms of brain swelling (edema). This study is specifically aimed at patients who require chronic high doses of dexamethasone to manage symptoms.

Dexamethasone Study: Impact on Quality of Life of Continuing Dexamethasone Following Emetogenic Chemotherapy [Recruiting]
Background: Dexamethasone is a steroid, which is often given into the vein before chemotherapy to help control acute nausea and vomiting. It can also be given as an oral tablet for patients to take for the two days following chemotherapy to help minimise delayed nausea and vomiting. In chemotherapy regimens that cause high rates of nausea and vomiting, the use of dexamethasone is well proven. However, in chemotherapy regimens that generally cause only minimal to moderate rates of nausea and vomiting, the value of oral dexamethasone in the 48-hour period after chemotherapy is not well proven, although it is often prescribed. While dexamethasone does decrease nausea, it causes additional side-effects such as insomnia, indigestion, anxiety and mood changes. While patients with less vomiting and nausea are expected to have better quality of life (QOL), for patients with minimal nausea or vomiting, their QOL might be more affected by the side effects of the dexamethasone treatment than by the nausea.

Study Design: The study will be performed in patients who will be receiving first line chemotherapy treatment with a moderate risk of nausea/vomiting. Anti-nausea therapy for acute nausea/vomiting will be standardised and all patients will receive non-steroidal medication for delayed nausea control. Each patient will be randomly allocated to receive either oral dexamethasone or an identical appearing placebo tablet for two days after chemotherapy for the first cycle of chemotherapy, and then crossed over to the other treatment for the second cycle. Patients will complete QOL assessments, dexamethasone symptom and nausea and vomiting questionnaires, as well as nausea/vomiting diaries. This will enable the researchers to determine the effect of dexamethasone on nausea and vomiting and the impact of both the side effects of dexamethasone, and of nausea and vomiting, on QOL.

Objectives: The primary objectives are to determine patient preference for dexamethasone or placebo, and to compare changes in QOL after chemotherapy in patients who receive dexamethasone with those who receive placebo. The secondary objectives are: (1) to compare complete protection from delayed vomiting and severity of nausea; (2) to compare differences in the impact of nausea and vomiting on QOL, and (3) to compare differences in symptoms that have been associated with dexamethasone (insomnia, anxiety, agitation, mood, etc.) between patients receiving dexamethasone and those receiving placebo.

Significance: This study will provide data to evaluate whether the benefits of dexamethasone for delayed nausea and vomiting outweigh potential side effects in patients receiving chemotherapy with a moderate risk of causing nausea and vomiting. This addresses a problem that is important to a majority of patients receiving anticancer chemotherapy. If overall QOL is improved on dexamethasone, then it should be prescribed more frequently, but if QOL is reduced on dexamethasone, and patients prefer the placebo, then its use as an anti-nausea medication for delayed nausea after moderately nauseating chemotherapy should be limited to patients with poor initial control of nausea/vomiting.

Aprepitant With Dexamethasone Versus Ondansetron With Dexamethasone for PONV Prophylaxis in Patients Having Craniotomy [Recruiting]
We hypothesize that the combination of aprepitant with dexamethasone will provide significantly improved prophylaxis against Postoperative nausea and vomiting compared with the combination of ondansetron and dexamethasone, in patients undergoing craniotomy under general anesthesia.

Vincristine, DOXIL® (Doxorubicin HCl Liposome Injection) and Dexamethasone vs. Vincristine, Doxorubicin, and Dexamethasone in Patients With Newly Diagnosed Multiple Myeloma [Completed]
The purpose of this study is to determine how well newly diagnosed multiple myeloma patients respond to an experimental regimen of Vincristine, DOXIL (doxorubicin HCl liposome injection) and Dexamethasone (VDD) versus the standard treatment of Vincristine, Doxorubicin and Dexamethasone (VAD).

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Reports of Suspected Maxidex (Dexamethasone Ophthalmic) Side Effects

Intraocular Pressure Increased (5),  Corneal Thickening (3),  Transplant Failure (2),  Post Procedural Complication (2),  Visual Acuity Reduced (2),  Transplant Rejection (2),  Corneal Opacity (2),  Endophthalmitis (2),  Corneal Decompensation (2),  Lens Extraction (1), more >>