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Msir (Morphine Sulfate) - Indications and Dosage

 
 



INDICATIONS AND USAGE

MSIR Oral Solution Concentrate and MSIR Tablets are indicated for the relief of moderate to severe pain.

DOSAGE AND ADMINISTRATION

(See also: CLINICAL PHARMACOLOGY, WARNINGS and PRECAUTIONS sections)

WARNING: DRUG CONCENTRATE--CHECK DOSAGE AND MEASURE ACCURATELY.

Dosage of morphine is a patient-dependent variable, which must be individualized according to patient metabolism, age and disease state, and also response to morphine. Each patient should be maintained at the lowest dosage level that will produce acceptable analgesia. As the patient's well-being improves after successful relief of moderate to severe pain, periodic reduction of dosage and/or extension of dosing interval should be attempted to minimize exposure to morphine.

Usual Adult Oral Dose:    5 to 30 mg every four (4) hours or as directed by physician, administered either as MSIR Oral Solution Concentrate or MSIR Tablets. For control of pain in terminal illness, it is recommended that the appropriate dose of MSIR Oral Solution Concentrate or MSIR Tablets be given on a regularly scheduled basis every four hours at the minimum dose to achieve acceptable analgesia. If converting a patient from another narcotic to morphine sulfate on the basis of standard equivalence tables, a 1 to 3 ratio of parenteral to oral morphine equivalence is suggested. This ratio is conservative and may underestimate the amount of morphine required. If this is the case, the dose of MSIR Oral Solution Concentrate and MSIR Tablets should be gradually increased to achieve acceptable analgesia and tolerable side effects.

HOW SUPPLIED

MSIR (morphine sulfate) Oral Solution Concentrate:

20 mg per 1 mL unflavored, clear, colorless liquid

NDC 0034-0523-01: plastic bottle with child-resistant dropper in 30 mL size.

NDC 0034-0523-02: plastic bottle with child-resistant dropper in 120 mL size.

Discard opened bottle of Oral Solution after 90 days. Protect from light.

MSIR (morphine sulfate) Tablets:

15 mg round, white scored tablets

NDC 0034-0518-10: opaque plastic bottle containing 100 tablets. Each tablet bears the symbol PF on the scored side and MI 15 on the other side.

30 mg capsule-shaped, white scored tablets

NDC 0034-0519-10: opaque plastic bottle containing 100 tablets. Each tablet bears the symbol PF on the scored side and MI 30 on the other side.

Store MSIR Oral Solution Concentrate and MSIR Tablets at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F).

CAUTION

DEA Order Form Required.

©1985, 2004

The Purdue Frederick Company

The Purdue Frederick Company

Stamford, CT 06901-3431

March 17, 2004

IT00318B 091930-0D-001

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