Conzip
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Questions & Answers
Side Effects & Adverse Reactions
There is currently no warning information available for this product. We apologize for any inconvenience.
Legal Issues
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FDA Safety Alerts
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Manufacturer Warnings
There is currently no manufacturer warning information available for this drug.
FDA Labeling Changes
There are currently no FDA labeling changes available for this drug.
Uses
Tramadol Hydrochloride Extended-Release 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.
History
There is currently no drug history available for this drug.
Other Information
Tramadol Hydrochloride Extended-Release Capsules is a centrally acting synthetic analgesic in an extended-release oral formulation. The chemical name for tramadol hydrochloride USP is (±)cis-2-[(dimethylamino)methyl]-1-(3-methoxyphenyl) cyclohexanol hydrochloride. Its structural formula is:
Figure 1
C16 H25 NO2 . HCl
The molecular weight of tramadol hydrochloride, USP is 299.8. It is a white, bitter, crystalline and odorless powder that is readily soluble in water and ethanol and has a pKa of 9.41. The n-octanol/water log partition coefficient (logP) is 1.35 at pH 7. Tramadol Hydrochloride Extended-Release Capsules contain a total dose of tramadol hydrochloride USP 100, 200 and 300 mg in a combination of immediate-release and extended-release components.
| Dosage | Immediate-release | Extended-release |
| 100 mg | 25 mg | 75 mg |
| 200 mg | 50 mg | 150 mg |
| 300 mg | 50 mg | 250 mg |
Tramadol Hydrochloride Extended-Release Capsules are white in color. Inactive ingredients include gelatin, titanium dioxide, shellac, FD & C Blue #2 aluminum lake (E132), D & C Red #7 calcium lake (E180), D & C Yellow #10 aluminum lake, lactose monohydrate 200 mesh, microcrystalline cellulose, povidone K30, corn starch, sodium starch glycolate, magnesium stearate, sucrose stearate, hypromellose, talc, polysorbate 80, Eudragit NE 30D, and simethicone emulsion.
Sources
Conzip Manufacturers
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Trigen Laboratories, Llc
![Conzip (Tramadol Hydrochloride) Capsule [Trigen Laboratories, Llc]](/wp-content/themes/bootstrap/assets/img/loading2.gif)
Conzip | Trigen Laboratories, Llc
2.1 General Dosing ConsiderationsTramadol Hydrochloride Extended-Release is an extended-release formulation intended for once a day dosing in adults aged 18 years and older. The capsules must be swallowed whole with liquid and must not be split, chewed, dissolved or crushed. Chewing, crushing or splitting the capsule could result in the uncontrolled delivery of tramadol, in overdose and death [see WARNINGS AND PRECAUTIONS (5.11), DRUG ABUSE AND DEPENDENCE (9), and OVERDOSE (10.1)].
Do not administer Tramadol Hydrochloride Extended-Release at a dose exceeding 300 mg per day. Do not use Tramadol Hydrochloride Extended-Release more than once daily or concomitantly with other tramadol products [see WARNINGS AND PRECAUTIONS (5.12)].
2.2 Patients Not Currently on Tramadol Immediate-Release ProductsInitiate treatment with Tramadol Hydrochloride Extended-Release 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.
2.3 Patients Currently on Tramadol Immediate-Release ProductsCalculate the 24-hour tramadol IR dose and initiate a total daily dose of Tramadol Hydrochloride Extended-Release 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 Tramadol Hydrochloride Extended-Release, some patients maintained on tramadol IR products may not be able to convert to Tramadol Hydrochloride Extended-Release.
2.4 Patients 65 Years of Age and OlderInitiate 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. Tramadol Hydrochloride Extended-Release should be administered with even greater caution in patients over 75 years, due to the greater frequency of adverse events seen in this population.
2.5 Patients with Renal ImpairmentThe 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 renal impairment. Do not use Tramadol Hydrochloride Extended-Release in patients with creatinine clearance less than 30 mL/min [see USE IN SPECIFIC POPULATIONS (8.6) and CLINICAL PHARMACOLOGY (12.3)].
2.6 Patients with Hepatic ImpairmentThe 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 Tramadol Hydrochloride Extended-Release in patients with severe hepatic impairment (Child-Pugh Class C) [see USE IN SPECIFIC POPULATIONS (8.7) and CLINICAL PHARMACOLOGY (12.3)].
2.7 Discontinuation of TreatmentWithdrawal symptoms may occur if Tramadol Hydrochloride Extended-Release is discontinued abruptly. Clinical experience with tramadol suggests that withdrawal symptoms may be reduced by tapering Tramadol Hydrochloride Extended-Release [see WARNINGS AND PRECAUTIONS (5.10) and DRUG ABUSE AND DEPENDENCE (9.3)].
2.8 Food EffectsTramadol Hydrochloride Extended-Release may be taken without regard to food [see CLINICAL PHARMACOLOGY (12.3)].
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Vertical Pharmaceuticals Inc.
Conzip | Vertical Pharmaceuticals Inc.
2.1 General Dosing ConsiderationsConZip™ 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 (5.11), DRUG ABUSE AND DEPENDENCE (9), and OVERDOSE (10.1)].
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 (5.12)].
2.2 Patients Not Currently on Tramadol Immediate-Release ProductsInitiate 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.
2.3 Patients Currently on Tramadol Immediate-Release ProductsCalculate 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™.
2.4 Patients 65 Years of Age and OlderInitiate 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.
2.5 Patients with Renal ImpairmentThe 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 (8.6) and CLINICAL PHARMACOLOGY (12.3)].
2.6 Patients with Hepatic ImpairmentThe 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 (8.7) and CLINICAL PHARMACOLOGY (12.3)].
2.7 Discontinuation of TreatmentWithdrawal 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 (5.10) and DRUG ABUSE AND DEPENDENCE (9.3)].
2.8 Food EffectsConZip™ may be taken without regard to food [see CLINICAL PHARMACOLOGY (12.3)].
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Vertical Pharmaceuticals, Llc
Conzip | Vertical Pharmaceuticals, Llc
2.1 General Dosing ConsiderationsConZip® is an extended-release formulation intended for once a day dosing in adults aged 18 years and older. The capsules must be swallowed whole with liquid and must not be split, chewed, dissolved or crushed. Chewing, crushing or splitting the capsule could result in the uncontrolled delivery of tramadol, in overdose and death [see WARNINGS AND PRECAUTIONS (5.11), DRUG ABUSE AND DEPENDENCE (9), and OVERDOSE (10.1)].
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 (5.12)].
2.2 Patients Not Currently on Tramadol Immediate-Release ProductsInitiate 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.
2.3 Patients Currently on Tramadol Immediate-Release ProductsCalculate 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®.
2.4 Patients 65 Years of Age and OlderInitiate 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.
2.5 Patients with Renal ImpairmentThe 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 (8.6) and CLINICAL PHARMACOLOGY (12.3)].
2.6 Patients with Hepatic ImpairmentThe 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 (8.7) and CLINICAL PHARMACOLOGY (12.3)].
2.7 Discontinuation of TreatmentWithdrawal 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 (5.10) and DRUG ABUSE AND DEPENDENCE (9.3)].
2.8 Food EffectsConZip® may be taken without regard to food [see CLINICAL PHARMACOLOGY (12.3)].
![Conzip (Tramadol Hydrochloride) Capsule, Extended Release [Vertical Pharmaceuticals Inc.]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=2347726f-7755-7026-426c-6f7741776179&name=con07-0000-04.jpg)
![Conzip (Tramadol Hydrochloride) Capsule, Extended Release [Vertical Pharmaceuticals, Llc]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=a65b4d05-3a1c-4aa1-848a-d20ac9aaf62f&name=con0h-0000-04.jpg)
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