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ConZip

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ConZip

Indications
Dosage
How Supplied

INDICATIONS

ConZip™ is indicated for the management of moderate to moderately severe chronic pain in adults who require around-the-clock treatment of their pain for an extended period of time.

DOSAGE AND ADMINISTRATION

General Dosing Considerations

ConZip™ is an extended-release formulation intended for once a day dosing in adults aged 18 years and older. The tablets must be swallowed whole with liquid and must not be split, chewed, dissolved or crushed. Chewing, crushing or splitting the tablet could result in the uncontrolled delivery of tramadol, in overdose and death [see WARNINGS AND PRECAUTIONS, Drug Abuse And Dependence, and OVERDOSE].

Do not administer ConZip™ at a dose exceeding 300 mg per day. Do not use ConZip™ more than once daily or concomitantly with other tramadol products [see WARNINGS AND PRECAUTIONS].

Patients Not Currently on Tramadol Immediate-Release Products

Initiate treatment with ConZip™ at a dose of 100 mg once daily and titrated up as necessary by 100 mg increments every five days to achieve a balance between relief of pain and tolerability.

Patients Currently on Tramadol Immediate-Release Products

Calculate the 24-hour tramadol IR dose and initiate a total daily dose of ConZip™ rounded down to the next lowest 100 mg increment. The dose may subsequently be individualized according to patient need. Due to limitations in flexibility of dose selection with ConZip™, some patients maintained on tramadol IR products may not be able to convert to ConZip™.

Patients 65 Years of Age and Older

Initiate dosing of an elderly patient (over 65 years of age) should be initiated cautiously, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal or cardiac function and of concomitant disease or other drug therapy. ConZip™ should be administered with even greater caution in patients over 75 years, due to the greater frequency of adverse events seen in this population.

Patients with Renal Impairment

The limited availability of dose strengths and once daily dosing of ConZip™ do not permit the dosing flexibility required for safe use in patients with severe renal impairment. Do not use ConZip™ in patients with creatinine clearance less than 30 mL/min [see Use In Specific Populations and CLINICAL PHARMACOLOGY].

Patients with Hepatic Impairment

The limited availability of dose strengths and once daily dosing of tramadol hydrochloride extended-release capsules do not permit the dosing flexibility required for safe use in patients with severe hepatic impairment. Do not use ConZip™ in patients with severe hepatic impairment (Child-Pugh Class C) [see Use In Specific Populations and CLINICAL PHARMACOLOGY].

Discontinuation of Treatment

Withdrawal symptoms may occur if ConZip™ is discontinued abruptly. Clinical experience with tramadol suggests that withdrawal symptoms may be reduced by tapering ConZip™ [see WARNINGS AND PRECAUTIONS and Drug Abuse And Dependence].

Food Effects

ConZip™ may be taken without regard to food [see CLINICAL PHARMACOLOGY].

HOW SUPPLIED

Dosage Forms And Strengths

ConZip™ is available in 100 mg, 200 mg and 300 mg extended-release capsules.

100 mg Capsules: White capsule imprinted with blue ink “G 252” on cap and “100” between lines on the body

200 mg Capsules: White capsule imprinted with violet ink “G 253” on cap and “200” between lines on the body

300 mg Capsules: White capsule imprinted with red ink “G 254” on cap and “300” between lines on the body

Storage And Handling

ConZip™ capsules (tramadol hydrochloride) are supplied as opaque white hard gelatin capsules, imprinted as follows.

100 mg Capsules: White Capsule imprinted with blue ink “G 252” on cap and “100” between lines on the body

Bottle of 30 capsules: NDC 68025-053-30

200 mg Capsules: White capsule imprinted with violet ink “G 253” on cap and “200” between lines on the body

Bottle of 30 capsules: NDC 68025-055-30

300 mg Capsules: White capsule imprinted with red ink “G 254” on cap and “300” between lines on the body

Bottle of 30 capsules: NDC 68025-056-30

Storage

Dispense in a tight container. Store at 25°C; excursions permitted to 15°C to 30°C (59°F to 86°F). Keep out of reach of children.

Manufactured for: Vertical Pharmaceuticals, Inc., Sayreville, NJ 08872 USA. by: Galephar P R, Inc., Juncos, Puerto Rico 00777. Revised: June 2011

Last reviewed on RxList: 4/25/2013
This monograph has been modified to include the generic and brand name in many instances.

Indications
Dosage
How Supplied
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