Rx Product News

Oxecta

Marketed by: King Pharmaceuticals, a wholly owned subsidiary of Pfizer Inc (Bristol, TN)

Indication: Oxecta (oxycodone HCl, USP) tablets are now commercially available in the United States. Oxecta is indicated for the management of acute and chronic moderate-to-severe pain where the use of an opioid analgesic is appropriate. It is the first immediate-release oxycodone HCl tablet that uses technology designed to discourage common methods of tampering associated with opioid abuse and misuse. In opioid-naïve patients, Oxecta should be dosed at 5 to 15 mg every 4 to 6 hours as needed for pain. Immediately after being placed in the mouth, each tablet must be swallowed whole and should be taken with enough water to ensure complete swallowing.

Dosage Form: Tablets: 5 and 7.5 mg

For More Information: http://labeling.pfizer.com/ShowLabeling.aspx?id=620

BD AutoShield Duo

Marketed by: BD Medical, a segment of BD (Franklin Lakes, NJ)

Indication: BD AutoShield Duo is a safety-engineered 5-mm pen needle designed to protect health care workers from blood exposure and needle stick injuries. BD AutoShield Duo is the only pen needle with front- and back-end needle protection. Clinicians can use a one-handed injection technique with the BD AutoShield Duo and need not use a “pinch” technique, thereby minimizing the risk of needle stick through a fold of skin. After use, safety mechanisms automatically activate, eliminating the risk of exposure to contaminated needles. The 5-mm size also reduces the risk of accidental intramuscular injection. BD AutoShield Duo fits all insulin pens. Supplied as: 5-mm pen needles in boxes of 100

For More Information: www.bd.com/duo

Edarbyclor

Marketed by: Takeda Pharmaceuticals North America (Deerfield, IL)

Indication: The FDA approved Edarbyclor (azilsartan medoxomil/chlorthalidone) for the treatment of hypertension in patients whose blood pressure is not adequately controlled with monotherapy or as initial therapy in patients who likely need multiple drugs to achieve blood pressure goals. Edarbyclor is the only available fixed-dose combination of an angiotensin II receptor blocker with the diuretic chlorthalidone. The starting dose of Edarbyclor is 40/12.5 mg once daily. After 2 to 4 weeks, the dose may be increased if needed to 40/25 mg, which is the maximum dose. Edarbyclor may be taken with or without food, and can also be taken with other antihypertensive agents.

Dosage Form: Tablets (azilsartan/chlorthalidone): 40/12.5 and 40/25 mg

For More Information: www.edarbi.com

Subsys

Marketed by: INSYS Therapeutics (Phoenix, AZ)

Indication: INSYS Therapeutics announced the approval of Subsys (fentanyl sublingual spray), CII, an opioid agonist indicated for the management of breakthrough pain in cancer patients 18 years and older who are already receiving and who are tolerant to opioid therapy for their underlying, persistent cancer pain. Patients must remain on around-the-clock opioids when taking Subsys. The initial dose is 100 mcg, and patients should be titrated to the dose that provides adequate analgesia with a single administration per breakthrough pain episode. Subsys may only be dispensed to patients who are enrolled in the TIRF REMS Access Program.

Dosage Form: Sublingual spray: 100, 200, 400, 600, and 800 mcg

For More Information: www.insysrx.com/products/fentanylsl-spray

MetroGel 1%

Marketed by: Galderma Laboratories, LP (Fort Worth, TX)

Indication: Galderma Laboratories announced the availability of a new pump dispenser for MetroGel (metronidazole) Gel 1%, a nitroimidazole indicated for the topical treatment of inflammatory lesions of rosacea. MetroGel 1% is not for oral, ophthalmic, or intravaginal use. Patients should apply a thin film of MetroGel 1% to the affected areas once daily, after cleansing. Oral metronidazole has been reported to interfere with the anticoagulant effects of coumarin and warfarin. Although the absorption of metronidazole is low in a topical preparation, this potential interaction should be kept in mind when prescribed in patients receiving anticoagulant treatment.

Dosage Form: Gel: each g contains 10 mg of metronidazole

For More Information: www.metrogel.com

Isentress

Marketed by: Merck & Co, Inc (Whitehouse Station, NJ)

Indication: The FDA recently approved Isentress (raltegravir) for use in combination with other antiretroviral agents for the treatment of HIV-1 infection in pediatric patients 2 years and older who weigh at least 10 kg. Isentress, an HIV integrase strand transfer inhibitor, has not been studied in children younger than 2 years. The dose for children and adolescents 12 years and older is 1 film-coated 400-mg tablet taken orally twice daily. For children aged 2 to 12 years, the dosage is based on the child’s weight. The film-coated tablet formulation of Isentress cannot be substituted with the chewable tablets. Isentress can be given with or without food.

Dosage Form: Film-coated tablets: 400 mg; chewable tablets: 100 mg scored and 25 mg

For More Information: www.isentress.com