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Methadone : (methadone hydrochloride) Oral Tablets, USP
Methadone hydrochloride is chemically described as 6-(dimethylamino)-4,4-diphenyl-3-heptanone hydrochloride. Methadone hydrochloride is a white, crystalline material that is water-soluble. Methadone hydrochloride has a melting point of 235°C, and a pKa of 8.25 in water at 20°C. Its octanol/water partition coefficient at pH 7.4 is 117. A solution (1:100) in water has a pH between 4.5 and 6.5.
Methadone Oral Tablets (methadone hydrochloride tablets USP) each contain 5 or 10 mg of methadone hydrochloride, USP and the following inactive ingredients: dibasic calcium phosphate, microcrystalline cellulose, magnesium stearate, colloidal silicon dioxide, pregelatinized starch, and stearic acid.
Methadone Oral Tablets (methadone hydrochloride) Tablets, USP) are indicated for the:
-Management of moderate to severe pain when a continuous, around-the-clock opioid analgesic is needed for an extended period of time.
-Detoxification treatment of opioid addiction (heroin or other morphine-like drugs).
-Maintenance treatment of opioid addiction (heroin or other morphine-like drugs), in conjunction with appropriate social and medical services.
Limitations of Use
Methadone is not for use:
-As an as-needed (prn) analgesic
-For pain that is mild or not expected to persist for an extended period of time
-For acute pain
-For postoperative pain
Initial Dosing for Management of Pain:
Consider the following factors when selecting an initial dose of Methadone:
-Total daily dose, potency, and prior opioid the patient has been taking previously;
-Patient’s degree of opioid experience and opioid tolerance;
-General condition and medical status of the patient;
-Type and severity of the patient’s pain
Dosage Forms And Strengths
Methadone Oral Tablets (methadone hydrochloride tablets USP) is available in 10 mg dosage strengths. The 10 mg tablets are white, scored tablets (Identified METHADONE 10).
Storage And Handling
Methadone contains methadone which is a controlled substance. Like fentanyl, morphine, oxycodone, hydromorphone, and
oxymorphone, methadone is controlled under Schedule II of the Federal Controlled Substances Act. Methadose may be targeted for theft and diversion by criminals [see WARNINGS AND PRECAUTIONS].
Keep tightly closed. Dispense in a tight, light-resistant container.
Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature].
Methadone Oral Tablets (methadone hydrochloride tablets USP):
10 mg white, scored tablets (Identified METHADOSE 10)