Codrix

Acetaminophen and codeine is supplied in tablet form for oral administration.

Acetaminophen, 4'-hydroxyacetanalide, a slightly bitter, white, odorless, crystalline powder, is a non-opiate, non-salicylate analgesic and antipyretic. It has the following structural formula:

Codeine phosphate, 7,8-didehydro-4,5α-epoxy-3-methoxy-17-methylmorphinan-6α-ol phosphate (1:1) (salt) hemihydrate, a white crystalline powder, is a narcotic analgesic and antitussive. It has the following structural formula:

Each tablet contains:

Acetaminophen 500 mg

Codeine phosphate 15 mg

In addition each tablet contains the following inactive ingredients: Colloidal silicon dioxide, crospovidone, croscarmellose sodium, magnesium stearate, microcrystalline cellulose, povidone, pregelatinized starch and stearic acid.

The most frequently reported adverse reactions are drowsiness, lightheadedness, dizziness, sedation, shortness of breath, nausea and vomiting. These effects seem to be more prominent in ambulatory than in non-ambulatory patients, and some of these adverse reactions may be alleviated if the patient lies down.

Other adverse drug reactions include allergic reactions, euphoria, dysphoria, constipation, abdominal pain, pruritus, rash, thrombocytopenia, agranulocytosis.

At higher doses codeine has most of the disadvantages of morphine including respiratory depression.

Controlled Substance

Codrix™ is classified as a Schedule III controlled substance.

Abuse and Dependence

Codeine can produce drug dependence of the morphine type and, therefore, has the potential for being abused. Psychological dependence, physical dependence, and tolerance may develop upon repeated administration and it should be prescribed and administered with the same degree of caution appropriate to the use of other oral narcotic medications.

Codrix™, (acetaminophen and codeine phosphate tablets, USP) 500 mg/15 mg are oval, white tablets with the “” imprinted on one side and "711" imprinted on the other side.

Bottles of 100 Tablets        NDC 62022-711-01

Bottles of 500 Tablets        NDC 62022-711-05

Bottles of 1000 Tablets       NDC 62022-711-50

Store at controlled room temperature, 15 to 30°C (59 to 86°F) [see USP].

Dispense in tight, light-resistant container as defined in the USP.

Manufactured by:
Andrx Pharmaceuticals, Inc.
Fort Lauderdale, FL 33314

Manufactured for:
Andrx Laboratories, Inc.
Weston, FL 33331

Rev. date: 08/07
7210

Applies to acetaminophen / codeine: oral capsule, oral liquid, oral suspension, oral tablet

General

The most frequently observed adverse reactions include drowsiness, lightheadedness, dizziness, sedation, shortness of breath, nausea, and vomiting.[Ref]

Nervous system

Acetaminophen-codeine:
Common (1% to 10%): Drowsiness, dizziness
Frequency not reported: Lightheadedness, sedation, medication over-use headache

Acetaminophen:
Frequency not reported: Drowsiness, impaired mental functions

Opioids:
Frequency not reported: Confusion, drowsiness, vertigo, dizziness, CNS excitation (restlessness/excitement), convulsions, headache, raised intracranial pressure[Ref]

Gastrointestinal

Acetaminophen-codeine:
Frequency not reported: Nausea, vomiting, constipation, abdominal pain

Acetaminophen:
Very rare (less than 0.01%): Pancreatitis
Frequency not reported: Dyspepsia

Opioids:
Frequency not reported: Constipation, GI irritation, biliary spasm, nausea, vomiting, loss of appetite, dry mouth, paralytic ileus, toxic megacolon[Ref]

Hepatic

Acetaminophen:
Frequency not reported: Acute liver failure, hepatotoxicity, chronic hepatic necrosis, cytolytic hepatitis[Ref]

Psychiatric

Acetaminophen-codeine:
Frequency not reported: Euphoria, dysphoria

Opioid:
Frequency not reported: Confusion, changes in mood, hallucinations, mental depression, trouble sleeping or nightmares, tolerance or dependence[Ref]

Renal

Acetaminophen-codeine:
Frequency not reported: Renal failure, uremia

Acetaminophen:
Frequency not reported: Nephrotoxicity, papillary necrosis[Ref]

Hypersensitivity

Acetaminophen-codeine:
Frequency not reported: Allergic reactions

Acetaminophen:
Rare (less than 0.1%): Allergic reactions including skin rash, drug fever, mucosal lesions
Postmarketing reports: Hypersensitivity including swelling of the face, mouth, and throat, respiratory distress, urticaria, rash, pruritus, and vomiting, anaphylaxis, angioedema

Opioids:
Frequency not reported: Rash, urticaria, difficulty breathing, increased sweating, redness, redness or flushed face[Ref]

Cardiovascular

Acetaminophen:
Frequency not reported: Toxic myocarditis, Kounis syndrome

Opioids:
Frequency not reported: Bradycardia, palpitations, hypotension[Ref]

Genitourinary

Acetaminophen-codeine:
Frequency not reported: Urinary retention or hesitance

Opioids:
Frequency not reported: Urinary retention, ureteral spasm, antidiuretic effect[Ref]

Hematologic

Acetaminophen-codeine:
Frequency not reported: Thrombocytopenia, agranulocytosis, anemia

Acetaminophen:
Very rare (less than 0.01%): Thrombocytopenia, neutropenia, leucopenia
Frequency not reported: Agranulocytosis, methemoglobinemia, pancytopenia, thrombocytopenia purpura, hemolytic anemia[Ref]

Dermatologic

Acetaminophen-codeine:
Frequency not reported: Pruritus, rash

Acetaminophen:
Rare (less than 0.1%): Serious skin reactions such as acute generalized exanthematous pustulosis (AGEP), Stevens-Johnson Syndrome (SJS), and toxic epidermal necrolysis (TEN)
Frequency not reported: Sweating, fixed drug eruption[Ref]

Respiratory

In patients with a tendency of analgesic asthma acetaminophen-use has triggered bronchospasms.[Ref]

Acetaminophen-codeine:
Frequency not reported: Shortness of breath

Acetaminophen:
Frequency not reported: Bronchospasm

Codeine:
Frequency not reported: Respiratory depression[Ref]

Ocular

Opioids:
Frequency not reported: Blurred or double vision[Ref]

Some side effects of Codrix may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.