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Vicoprofen

Hydrocodone or dihydrocodeinone (marketed as Vicodin, Anexsia, Dicodid, Hycodan, Hycomine, Lorcet, Lortab, Norco, Tussionex, Vicoprofen) is an opioid derived from either of the naturally occurring opiates codeine or thebaine. Hydrocodone is an orally active narcotic analgesic and antitussive. The typical therapeutic dose of 5 to 10 mg is pharmacologically equivalent to 30 to 60 mg of oral codeine. Sales and production of this drug have increased significantly in recent years, as have diversion and illicit use. more...

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Hydrocodone is commonly available in tablet, capsule and syrup form.

As a narcotic, hydrocodone relieves pain by binding to opioid receptors in the brain and spinal cord. It may be taken with or without food, but should never be combined with alcohol. It may interact with monoamine oxidase inhibitors, as well as other drugs that cause drowsiness. It is in FDA pregnancy category C: its effect on an unborn embryo or fetus is not clearly known and pregnant women should consult their physicians before taking it. Common side effects include dizziness, lightheadedness, nausea, drowsiness, euphoria, vomiting, and constipation. Some less common side effects are allergic reaction, blood disorders, changes in mood, mental fogginess, anxiety, lethargy, difficulty urinating, spasm of the ureter, irregular or depressed respiration and rash.

Hydrocodone can be habit-forming, and can lead to physical and psychological addiction. In the U.S., pure hydrocodone and forms containing more than 15 mg per dosage unit are considered Schedule II drugs. Those containing less than 15 mg per dosage unit are Schedule III drugs. Hydrocodone is typically found in combination with other drugs such as paracetamol (acetaminophen), aspirin and homatropine methylbromide. In the UK it is listed as a Class A drug under the Misuse of Drugs Act 1971.

The presence of acetaminophen in hydrocodone-containing products deters many drug users from taking excessive amounts. However, some users will get around this by extracting a portion of the acetaminophen using hot/cold water, taking advantage of the water-soluble element of the drug. It is not uncommon for addicts to have liver problems from taking excessive amounts of acetaminophen over a long period of time--taking 10–15 grams of acetaminophen in a period of 24 hours typically results in severe hepatotoxicity. It is this factor that leads many addicts to use only single entity opiates such as OxyContin.

Symptoms of hydrocodone overdosage include respiratory depression, extreme somnolence, coma, stupor, cold/clammy skin, sometimes bradycardia, and hypotension. A severe overdose may involve circulatory collapse, cardiac arrest and/or death.

Notes

^ Tarascon Pocket Pharmacopoeia.

Read more at Wikipedia.org

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Knoll Pharmaceutical Receives Marketing Clearance For Vicoprofen
From Business Wire, 9/24/97

MT. OLIVE, N.J.--(BW HealthWire)--Sept. 24, 1997--

First and Only Opioid/Ibuprofen Combination Product For

Treatment of Acute Pain is Now Available

Knoll(R) Pharmaceutical Co. announced today that it has received clearance from the US Food and Drug Administration (FDA) to market Vicoprofen(R) CIII (hydrocodone bitartrate(a) and ibuprofen tablets, 7.5 mg/200 mg).

Vicoprofen will be the first and only opioid/ibuprofen combination indicated for the treatment of acute pain and offers unique analgesic advantages including the additive effect of hydrocodone plus ibuprofen -- providing better pain relief than either of the components alone at the same doses.

In clinical studies, one tablet of Vicoprofen was as effective as two tablets of acetaminophen and codeine phosphate (300 mg/30 mg).

Vicoprofen is clinically proven to relieve acute pain in a broad range of applications including sprains/strains, post-surgery, back disorders, dental pain, sport injuries, and fractures/dislocations.

Vicoprofen has been shown to have excellent patient acceptance. The most common side effects were nausea (21.0%), sleepiness (22.0%), dizziness (14.0%), headache (27.0%), constipation (22.0%) and dyspepsia (12.0%).

Vicoprofen should not be given to patients in whom aspirin or other nonsteroidal anti-inflammatory drugs induce asthma, uriticaria, or other allergic-type reactions. Serious gastrointestinal toxicity, such as inflammation, bleeding, ulceration, and perforation of the stomach, small intestine or large intestine can occur at any time, with or without warning symptoms, in patients treated with nonsteroidal anti-inflammatory drugs (NSAIDs). As with any opioid analgesic, the usual precautions should be observed regarding the impairment of mental and/or physical ability. These effects may be additive with alcohol and other Central Nervous System depressants.

According to the National Institutes of Health (NIH), an estimated 90 million Americans require treatment for pain at some point in their lives. In the United States, recurrent pain costs as much as $90 billion in doctor's fees, drugs, compensation, and litigation expenses each year.

Vicoprofen is the latest addition to Knoll's comprehensive line of pain management products including the Vicodin(R)(b) line, indicated for the relief of moderate to moderately severe pain and Dilaudid(R)(c) and Dilaudid HP(R)(d) for the treatment of moderate to severe pain which frequently affects patients with cancer and AIDS.

Earlier this year, Knoll entered into an agreement with ALZA Corp. for the development and worldwide commercialization of an innovative hydromorphone product which utilizes ALZA's advanced oral osmotic (OROS(R)) technology designed for the 24-hour management of severe chronic pain.

Knoll Pharmaceutical Co., headquartered in Mt. Olive, N.J., is the U.S. pharmaceutical unit of BASF Corp. and part of BASF Pharma, the global pharmaceutical division of BASF AG. Knoll Pharmaceutical Co. is dedicated to the development and marketing of prescription drugs for cardiovascular disease, pain management, endocrine, oncology, immune, thyroid disease and obesity.

(a) WARNING: May be habit forming.

(b) hydrocodone bitartrate and acetaminophen tablets, USP.

Warning: May be habit forming.

May be habit forming

hydromorphone HCL injection, USP. 1 mg/2 mg, 4 mg/mL.

Warning: May be habit forming.

(d) hydromorphone HCL injection, USP. 10 mg/mL injection.

Warning: May be habit forming.

CONTACT: Knoll Pharmaceutical Co., Mt. Olive

Linda Mayer, 973/426-5759

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