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an anticholinergic and antimuscarinic having direct antispasmodic effects on smooth muscle; used orally as the chloride salt in treatment of uninhibited neurogenic bladder and reflex neurogenic bladder.


Cystrin (UK), Kentera (UK), Oxytrol

oxycodone hydrochloride

Oxecta, OxyContin, Oxynorm (UK), Roxicodone, Supeudol (CA)

Pharmacologic class: Opioid agonist

Therapeutic class: Narcotic analgesic

Controlled substance schedule II

Pregnancy risk category B

FDA Box Warning

• Drug is opioid agonist and Schedule II controlled substance, with abuse potential similar to morphine. This potential must be considered when prescribing or dispensing drug.

• Extended-release tablets are indicated for managing moderate to severe pain when continuous, around-the-clock analgesia is needed for extended period of time. Extended-release tablets aren't intended for as-needed analgesia.

• Extended-release 80-mg tablets are for use only in opioid-tolerant patients. This strength may cause fatal respiratory depression when given to patients without previous opioid exposure.

• Instruct patients to swallow extended-release tablets whole. Caution them not to break, chew, or crush them, as this causes rapid release and absorption of potentially fatal dose.


Unknown. Thought to interact with opioid receptor sites primarily in limbic system, thalamus, and spinal cord, blocking transmission of pain impulses.


Capsules (immediate-release): 5 mg

Solution (oral): 5 mg/5 ml

Tablets: 5 mg, 7.5 mg, 10 mg, 15 mg, 20 mg, 30 mg

Tablets (controlled-release): 10 mg, 15 mg, 20 mg, 30 mg, 40 mg, 60 mg, 80 mg

Indications and dosages

Moderate to severe pain

Adults: 5 mg P.O. q 6 hours p.r.n., increased gradually to 10 to 30 mg q 6 hours p.r.n.

Moderate or severe pain when continuous around-the-clock analgesia is needed

Adults: 10 mg P.O. (controlled-release) q 12 hours. For patients already taking opioids, use total oral oxycodone daily equianalgesic dosage and then round down to closest tablet strength. For breakthrough pain, give supplemental immediate-release doses.

Dosage adjustment

• Hepatic disease

• Renal impairment

• Debilitated or opioid-naive patients

Off-label uses

• Postherpetic neuralgia (controlled release form)


• Hypersensitivity to drug

• Paralytic ileus

• When opioids are contraindicated (as in respiratory depression, severe bronchial asthma, hypercarbia)


Use cautiously in:

• head trauma; increased intracranial pressure (ICP); severe renal, hepatic, or pulmonary disease; hypothyroidism; adrenal insufficiency; urethral stricture; undiagnosed abdominal pain or prostatic hyperplasia; extensive burns; alcoholism

• history of substance abuse

• prolonged or high-dose therapy

• elderly or debilitated patients

• labor and delivery

• pregnant or breastfeeding patients

• children younger than age 18.


• Be aware that drug has high abuse potential.

• Know that controlled-release Oxy-Contin isn't indicated for p.r.n. pain control but is reserved for patients who need continuous, around-the-clock analgesia.

• Be aware that 80-mg controlled-release tablets are for opioid-tolerant patients only.

Never break, crush, or let patient chew controlled-release forms. Otherwise, rapid release and absorption of potentially fatal dose may occur.

• Give Oxecta tablets whole. Don't crush or dissolve tablets or administer by nasogastric, gastric, or other feeding tubes, because this may cause obstruction of feeding tubes.

• When discontinuing, taper dosage gradually to prevent withdrawal symptoms.

Adverse reactions

CNS: dizziness, asthenia, drowsiness, euphoria, light-headedness, insomnia, confusion, anxiety, twitching, abnormal dreams and thoughts

CV: orthostatic hypotension, circulatory depression, bradycardia, shock

GI: nausea, vomiting, constipation, diarrhea, ileus, abdominal pain, dyspepsia, gastritis, anorexia

GU: urinary retention

Respiratory: apnea, respiratory depression, respiratory arrest

Skin: pruritus, sweating

Other: chills, fever, hiccups, physical and psychological drug dependence


Drug-drug. Antihistamines, sedative-hypnotics: additive CNS depression

Barbiturates, protease inhibitors: increased respiratory and CNS depression

Opioid agonist-antagonists: precipitation of opioid withdrawal in physically dependent patients

Drug-diagnostic tests. Amylase, lipase: increased levels

Drug-behaviors. Alcohol use: additive CNS depression

Patient monitoring

Monitor vital signs and respiratory status. Withhold drug in significant respiratory or CNS depression.

• Assess patient's pain level frequently.

• Monitor bowel and bladder function.

• Assess patient for anxiety, twitching, and other CNS symptoms.

• Closely monitor head-trauma patient. Drug may increase ICP while masking signs and symptoms.

• Carefully assess patient with acute abdominal pain. Drug may obscure diagnosis.

• Stay alert for drug hoarding, tolerance, and dependence.

Patient teaching

Caution patient not to break, crush, chew, or dissolve controlled-release tablets. Warn him that doing so may cause rapid drug release and absorption (possibly fatal).

• Tell patient taking controlled-release form not to drive for 3 to 4 days after dosage increase, after consuming even a single alcoholic beverage, or if also taking antihistamines or other drugs that cause drowsiness.

• Tell patient to take Oxecta tablets whole.

Instruct patient to promptly report adverse reactions, especially difficulty breathing or slow pulse.

• Advise patient not to drink alcohol.

• Tell patient not to be alarmed if controlled-release tablets appear in stools; drug has already been absorbed.

• Advise ambulatory patient to change position slowly, to avoid dizziness from orthostatic hypotension.

• Instruct patient to consult prescriber before taking other drugs.

• Caution patient to avoid driving and other hazardous activities, because drug may cause drowsiness or dizziness.

• As appropriate, review all other significant and life-threatening adverse reactions and interactions, especially those related to the drugs, tests, and behaviors mentioned above.


/oxy·bu·ty·nin/ (-bu´tĭ-nin) an anticholinergic having direct antispasmodic effect on smooth muscle; used as the chloride salt in the treatment of uninhibited or reflex neurogenic bladder.


An anticholinergic drug, C22H31NO3, used to treat incontinence and other urinary symptoms.


Ditropan® Urology A spasmolytic anticholinergic GI and GU tract colic used to ↓ urge incontinence, overactive bladder, bladder Sx associated with neurogenic bladder–eg, frequency, urgency, dysuria, urinary leakage Contraindications Urinary retention, gastric retention, narrow-angle glaucoma Adverse effects Dry mouth, constipation, somnolence, diarrhea, blurred vision, dry eyes, dizziness, rhinitis. See Urge incontinence.


An anticholinergic antispasmodic drug used to treat urinary urgency, frequency and incontinence and bed-wetting in children. Brand names are Cystrin, Ditropan and Lyrinel XL.


an anticholinergic having direct antispasmodic effect on smooth muscle; used in the treatment of uninhibited neurogenic bladder and reflex neurogenic bladder.
References in periodicals archive ?
Acura had entered into another letter agreement with Pfizer in Sep 2012, where the latter returned to the former all the products licensed to it under the original license agreement except for Oxecta.
Acura's license grant to Pfizer for the Aversion technology has also been terminated and Acura now owns all rights to Oxecta tablets.
Specialty pharmaceutical company Acura Pharmaceuticals Inc (Nasdaq: ACUR) announced on Monday the expansion of commercialisation of OXECTA (oxycodone HCl) Tablets CII by Pfizer Inc (NYSE: PFE) to health care providers in US in the fourth quarter of 2013.
OXECTA is the reportedly the first immediate-release oxycodone HCl tablet that applies AVERSION technology.
Food and Drug Administration accepted OXECTA which incorporates Acura Pharmaceuticals' proprietary AVERSION technology, in June 2011.
OXECTA is covered by US patents issued to Acura and licensed to Pfizer Inc (NYSE:PFE).
24 January 2012 - Acura Pharmaceuticals, Inc (NASDAQ:ACUR) said on Monday it had received information from Pfizer Inc (NYSE:PFE) on the commercial availability of OXECTA (oxycodone HCl, USP) Tablets CII.
Acura Pharmaceuticals Inc (Nasdaq:ACUR), a speciality pharmaceutical company, announced on Monday that it has been informed by Pfizer Inc (NYSE: PFE) that OXECTA (oxycodone HCl, USP) Tablets CII are now commercially available.
M2 PHARMA-October 17, 2011-Pfizer to start commercialisation of OXECTA in US(C)2011 M2 COMMUNICATIONS
M2 EQUITYBITES-July 4, 2011-Acura Pharmaceuticals Inc awarded USD20m milestone payment for FDA's approval of Pfizer Inc's OXECTA used against tampering associated with opioid abuse(C)2011 M2 COMMUNICATIONS http://www.