STATEX Oral Drops, Suppositories, Oral Syrup, Tablets Ref.[27922] Active ingredients: Morphine

Source: Health Products and Food Branch (CA)  Revision Year: 2019 

Product name

STATEX – Morphine sulfate.

Oral Drops: 50 mg/mL
Suppositories: 5, 10, 20 and 30 mg
Oral Syrup: 1 and 5 mg/mL
Tablets: 5, 10, 25 and 50 mg

Summary product information

Route of AdministrationDosage Form/StrengthNonmedicinal Ingredients
OralOral drop 50 mg/mLCitric acid anhydrous, dextrose monohydrate, glycerine, sodium benzoate, sodium cyclamate, propylene glycol, water
Oral syrup 1 and 5 mg/mLUnflavoured: citric acid anhydrous, dextrose monohydrate, glycerine, sodium benzoate, sodium cyclamate, propylene glycol, water Orange flavour: citric acid anhydrous, glycerine, orange extract, propylene glycol, sodium benzoate, sucrose, water
Tablet 5, 10, 25 and 50 mgFD&C Blue No.1 Lake 13% (5mg, 10mg), FD&C red #3 Lake 15% (25mg, 50mg) lactose monohydrate, lake blend yellow 17% LB-111 (5mg, 50mg), magnesium stearate, microcrystalline cellulose
RectalSuppository 5, 10, 20 and 30 mgWecobee M (hydrogenated vegetable oil)

For a complete listing see Dosage Forms, Composition and Packaging section.

Dosage forms, composition and packaging

Composition

Statex Oral Drop 50 mg/ mL: Each 1mL of clear unflavored and colorless liquid contains 50 mg of morphine sulfate. The non-medicinal ingredients are citric acid anhydrous, dextrose monohydrate, glycerine, sodium benzoate, sodium cyclamate, propylene glycol, water. Calorie content: 160 KCal/100 mL.

Statex Oral Syrup 1 mg/mL: Available as unflavored (clear) and orange flavored syrup. Each mL contains 1 mg of morphine sulfate. The non-medicinal ingredients of the unflavoured syrup are citric acid anhydrous, dextrose monohydrate, glycerine, propylene glycol, sodium benzoate, sodium cyclamate, water. The non-medicinal ingredients of the orange flavoured syrup are citric acid anhydrous, glycerine, orange extract, propylene glycol, sodium benzoate, sucrose, water.

Statex Oral Syrup 5 mg/mL: Available as unflavoured (clear) and orange flavoured syrup. Each mL contains 5 mg of morphine sulfate. The non-medicinal ingredients of the unflavoured syrup are citric acid anhydrous, dextrose monohydrate, glycerine, propylene glycol, sodium benzoate, sodium cyclamate, water. The non-medicinal ingredients of the orange flavoured syrup are citric acid anhydrous, glycerine, orange extract, propylene glycol, sodium benzoate, sucrose, water.

Statex Suppositories: Each white cone-shape suppository contains: morphine sulfate 5, 10, 20, or 30 mg. The non-medicinal ingredient is wecobee M (hydrogenated vegetable oil).

Statex Oral Tablets: available as 5mg (green), 10 mg (blue), 25 mg (pink), 50 mg (orange) round, scored on one side, identified with Paladin logo on the other side tablets. The nonmedicinal ingredients are FD&C Blue No.1 Lake 13% (5mg, 10mg), lactose monohydrate, lake blend yellow 17% (5mg, 50mg), FD&C red#3, Lake 15% (25mg, 50mg), magnesium stearate, microcrystalline cellulose.

Packaging

Statex Oral Drops 50 mg/ mL: Available in 50 mL non-graduated bottles with calibrated dropper, filled to deliver 1 mL (50 mg of Morphine Sulfate).

Statex Oral Syrup 1 mg/mL: Available in 250 and 500 mL graduated bottles in Pet or Pet G bottles, and in uni-dose of 5, 10 and 15 mL (unflavoured only) in amber glass bottles.

Statex Oral Syrup 5 mg/mL: Available in 250 and 500 mL graduated bottles in Pet G bottles, and in uni-dose of 5 and 10 mL (unflavoured only) in amber glass bottles.

Statex Suppositories: Available in boxes of 10.

Statex Oral Tablets: Availabl in bottles of 100 or control packs of 100 (4 × 25 tablets in blister).

Marketing Informations Authorization Dates
Authorization holder:

Paladin Labs Inc., 100 Alexis Nihon Blvd., Suite 600, St-Laurent, Quebec, H4M 2P2

Submission control number:

229677

Date of approval:

December 4, 1985

Date of revision:

August 2, 2019

Drugs

Drug Countries
STATEX Canada, Singapore

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