concentrated oral gel

(redirected from Gelclair)

concentrated oral gel

,

Gelclair

(trade name)

Classification

Therapeutic: oral protectants
Pregnancy Category: UK

Indications

Management of oral pain due to:
  • oral mucositis/stomatitis (from chemotherapy or radiation),
  • irritation due to oral surgery,
  • traumatic ulcers caused by braces or poorly fitted dentures,
  • diffuse aphthous ulcers,
  • mouth ulcers caused by other diseases.

Action

Adheres to oral mucosal surface, providing a protective mechanical barrier over ulcerated areas.

Therapeutic effects

Decreased pain from oral ulcers.

Pharmacokinetics

Absorption: Action is local.
Distribution: Unknown.
Metabolism and Excretion: Unknown.
Half-life: Unknown.

Time/action profile (protectant effect)

ROUTEONSETPEAKDURATION
POrapidunknownas long as application remains on oral surface

Contraindications/Precautions

Contraindicated in: Hypersensitivity.
Use Cautiously in: None.

Adverse Reactions/Side Effects

None noted

Interactions

Drug-Drug interaction

None.

Route/Dosage

Oral (Adults) Use one packet 3 times daily, or as needed.

Availability

Concentrated oral gel: 15 mL packets in box of 21 packets

Nursing implications

Nursing assessment

  • Assess mouth ulcers prior to and periodically during therapy.
  • Assess severity of pain prior to and periodically during therapy.

Potential Nursing Diagnoses

Acute pain (Indications)

Implementation

  • Pour entire contents of single-dose packet into glass and add 15 mL or 1 tbsp of water. If mixture is too thick, add additional 15–30 mL of water to achieve desired consistency. Stir well and use at once. Store at room temperature; do not refrigerate. Gel may become darker or thicker over time, but this does not affect efficacy or safety. Do not use packets that are split or torn or beyond expiration date.
  • If water is not available, may be used undiluted.
  • Oral: Administer 3 times daily or as needed.

Patient/Family Teaching

  • Instruct patient on preparing and using Gelclair. Rinse around mouth for at least 1 min or as long as possible to coat tongue, palate, throat, inside of cheeks, and all oral tissue thoroughly. Gargle and spit out. Advise patient that no adverse effects are expected if Gelclair is swallowed accidently. Instruct patient not to eat or drink for at least 1 hr after treatment.
  • Instruct patient to keep product out of direct sunlight and to store at room temperature.

Evaluation/Desired Outcomes

  • Decrease in pain from oral ulcers. If no improvement in 7 days, notify health care professional.
References in periodicals archive ?
DARA holds exclusive US marketing rights to Gelclair oral rinse gel, Oravig (miconazole) buccal tablets and Soltamox (tamoxifen citrate oral liquid solution).
baking soda, 1 quart water (14) -- Avoid alcohol mouth rinses (20) *Chlorhexidine gluconate mouth rinse without alcohol to control plaque when oral hygiene compromised (14) -- Not prevention of OM (18), (19), (21) *Oral mucosa protectants -- Gelclair (22) and "magic mouthwashes" *Use of topical anesthetics (8), (23), (24) *Severe mucositis: Oncologist prescriptions -- Palifermin (17), (18), (22) (prevention) -- Helium-neon laser therapy (17), (19)
The deal has been signed for Gelclair, an FDA-approved bioadherent oral rinse gel to treat the aching symptoms of oral mucositis (OM), as well as Soltamox (tamoxifen citrate) oral liquid solution, to be available to RainTree's Nationwide Oncology Membership.
Gelclair is a concentrated gel, and Zilactin is a protective film.
In these cases, a prescription product called Gelclair may be recommended.
DARA plans to launch Gelclair in the first quarter of 2013.
It was reported on Friday that the contract has been signed for both Gelclair, an FDA-approved bioadherent oral rinse gel for treating the painful symptoms of oral mucositis, and Soltamox (tamoxifen citrate) oral liquid solution, to be accessible to RainTree's Nationwide Oncology Membership.
US-based oncology company DARA BioSciences Inc (NasdaqCM:DARA) reported on Thursday the execution of a pharmacy supply agreement for Gelclair and Soltamox with RainTree Oncology Services.
Those factors include risks and uncertainties relating to DARA's ability to timely commercialize and generate revenues or profits from Bionect[R], Soltamox[R], Gelclair[R] or other products given that DARA only recently hired its initial sales force and DARA's lack of history as a revenue-generating company, FDA and other regulatory risks relating to DARA's ability to market Bionect, Soltamox, Gelclair or other products in the U.
According to the agreement and a shared sales force agreement with Mission, in addition to promoting Dara's products Soltamox (tamoxifen citrate), Gelclair and Bionect, the Alamo sales team will also carry three Mission Pharmacal products: Ferralet 90 (for anemia), BINOSTO (alendronate sodium effervescent tablet indicated for the treatment of osteoporosis), and Aquoral (for chemotherapy/radiation therapy-induced dry mouth).
Funds Earmarked for Soltamox Commercial Activities, Gelclair Launch and Working Capital
Net proceeds will be used by DARA BioSciences Inc to fund expenses related to the commercialisation of its complementary portfolio of oncology and oncology supportive care pharmaceutical products, including expenses for the commercial activities related to Soltamox, Gelclair and Bionect and for working capital, business development and other general corporate purposes.