What is Codeine Phosphate and how is it used?

Codeine Phosphate is a prescription medicine used to treat the symptoms of mild to moderately severe pain. Codeine Phosphate may be used alone or with other medications.

Codeine Phosphate belongs to a class of drugs called Analgesics, Opioids.

It is not known if Codeine Phosphate is safe and effective in children.

What are the possible side effects of Codeine Phosphate?

Codeine Phosphate may cause serious side effects including:

• noisy breathing,
• sighing,
• shallow breathing,
• breathing that stops during sleep,
• slow heart rate,
• weak pulse,
• lightheadedness,
• confusion,
• unusual thoughts or behavior,
• feelings of extreme happiness or sadness,
• convulsions (seizures),
• problems with urination,
• nausea,
• vomiting,
• loss of appetite,
• dizziness, and
• worsening tiredness or weakness

Get medical help right away, if you have any of the symptoms listed above.

The most common side effects of Codeine Phosphate include:

• feeling dizzy or drowsy,
• constipation,
• nausea,
• vomiting, and
• stomach pain

Tell the doctor if you have any side effect that bothers you or that does not go away.

These are not all the possible side effects of Codeine Phosphate. For more information, ask your doctor or pharmacist.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

DESCRIPTION

WARNING – MAY BE HABIT FORMING

Codeine is an alkaloid obtained from opium or prepared from morphine by methylation and occurs as white crystals. Codeine effloresces slowly in dry air and is effected by light. The chemical name of codeine phosphate is 7,8-Didehydro-4,5alpha-epoxy-3-methoxy-17-methylmorphinan-6alpha-ol phosphate (1:1)(salt) hemihydrate and has the empirical formula of C18H21NO3·H3PO4·1/2H20. Its molecular weight is 406.4.

Each soluble tablet contains 30 mg (0.074 mmol) or 60 mg (0.15 mmol) of codeine phosphate. These tablets also contain lactose and sucrose.

Soluble tablets of codeine phosphate are freely soluble in water. They are intended for the preparation of solutions for parenteral administration. These tablets are not sterile. Codeine phosphate is an analgesic.

INDICATIONS

Codeine phosphate is an analgesic indicated for the relief of mild to moderate pain.

DOSAGE AND ADMINISTRATION

For Analgesia: Dosage should be adjusted according to the severity of the pain and the response of the patient.

Adults: 15 to 60 mg every 4 to 6 hours (usual adult dose, 30 mg).

Children: 1 Year of Age and Older – 0.5 mg/kg of b.d. weight or 15 mg/m2 of b.d. surface every 4 to 6 hours.

Soluble tablets codeine phosphate are administered subcutaneously or intramuscularly.

Solutions for injection should be prepared with sterile water and filtered through a 0.22 membrane filter.

Note: Do not use the solution if it is more than slightly discolored or contains a precipitate.