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ConZip
Overview
What is ConZip?
CONZIP (tramadol hydrochloride) is an opioid agonist in an extended-release oral formulation. The chemical name for tramadol hydrochloride USP is (±)2-[(dimethylamino)methyl]-1-(3-methoxyphenyl) cyclohexanol hydrochloride. Its structural formula is:
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.
CONZIP capsules contain a total dose of tramadol hydrochloride 100, 200, and 300 mg in a combination of immediate-release and extended-release components.
CONZIP 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.
What does ConZip look like?
What are the available doses of ConZip?
Extended-release capsules: 100 mg, 200 mg and 300 mg ()
What should I talk to my health care provider before I take ConZip?
How should I use ConZip?
CONZIP is indicated for the management of pain severe enough to require daily, around-the-clock, long term opioid treatment and for which alternative treatment options are inadequate.
Limitation of Use
CONZIP should be prescribed only by healthcare professionals who are knowledgeable in the use of potent opioids for the management of chronic pain.
What interacts with ConZip?
Sorry No Records found
What are the warnings of ConZip?
Sorry No Records found
What are the precautions of ConZip?
Sorry No Records found
What are the side effects of ConZip?
Sorry No records found
What should I look out for while using ConZip?
CONZIP is contraindicated for:
CONZIP is also contraindicated in patients with:
Addiction, Abuse, and Misuse
CONZIP exposes patients and other users to the risks of opioid addiction, abuse, and misuse, which can lead to overdose and death. Assess each patient's risk prior to prescribing CONZIP and monitor all patients regularly for the development of these behaviors and conditions
[see Warnings and Precautions ()]
Life-Threatening Respiratory Depression
Serious, life-threatening, or fatal respiratory depression may occur with use of CONZIP. Monitor for respiratory depression, especially during initiation of CONZIP or following a dose increase. Instruct patients to swallow CONZIP capsules intact, and not to split, break, chew, crush, or dissolve the contents of the capsules to avoid exposure to a potentially fatal dose of tramadol
[see Warnings and Precautions ()].
Accidental Ingestion
Accidental ingestion of/exposure to even one dose of CONZIP especially by children, can result in a fatal overdose of tramadol
[see Warnings and Precautions ()]
Ultra-Rapid Metabolism Of Tramadol And Other Risk Factors For Life-Threatening Respiratory Depression In Children
Life-threatening respiratory depression and death have occurred in children who received tramadol. Some of the reported cases occurred following tonsillectomy and/or adenoidectomy, and at least one case, the child had evidence of being an ultra-rapid metabolizer of tramadol due to a CYP2D6 polymorphism
[see Warnings and Precautions ()]
. CONZIP is contraindicated in children younger than 12 years of age and in children younger than 18 years of age following tonsillectomy and/or adenoidectomy
[see Contraindications ()]
. Avoid the use of CONZIP in adolescents 12 to 18 years of age who have other risk factors that may increase their sensitivity to the respiratory depressant effects of tramadol
[see Warnings and Precautions ()].
Neonatal Opioid Withdrawal Syndrome
Prolonged use of CONZIP during pregnancy can result in neonatal opioid withdrawal syndrome, which may be life-threatening if not recognized and treated, and requires management according to protocols developed by neonatology experts. If opioid use is required for a prolonged period in a pregnant woman, advise the patient of the risk of neonatal opioid withdrawal syndrome and ensure that appropriate treatment will be available
[see Warnings and Precautions ()]
Interactions with Drugs Affecting Cytochrome P450 Isoenzymes
The effects of concomitant use or discontinuation of cytochrome P450 3A4 inducers, 3A4 inhibitors, or 2D6 inhibitors with tramadol are complex. Use of cytochrome P450 3A4 inducers, 3A4 inhibitors, or 2D6 inhibitors with CONZIP requires careful consideration of the effects on the parent drug, tramadol, and the active metabolite, M1
[see Warnings and Precautions (), Drug Interactions ()].
Risks From Concomitant Use With Benzodiazepines Or Other CNS Depressants
Concomitant use of opioids with benzodiazepines or other central nervous system (CNS) depressants, including alcohol, may result in profound sedation, respiratory depression, coma, and death
[
see
Warnings and Precautions (), Drug Interactions ()]
What might happen if I take too much ConZip?
How should I store and handle ConZip?
Store at 20°–25° C (68°–77° F); excursions permitted to 15°–30° C (59°–86° F). [See USP Controlled Room Temperature.]Dispense in light-resistant containers.Manufactured for: Pulaski, TN 38478Mfg. Rev. 04/12AV Rev. 02/13 (P)Store at 20°–25° C (68°–77° F); excursions permitted to 15°–30° C (59°–86° F). [See USP Controlled Room Temperature.]Dispense in light-resistant containers.Manufactured for: Pulaski, TN 38478Mfg. Rev. 04/12AV Rev. 02/13 (P)Store at 20°–25° C (68°–77° F); excursions permitted to 15°–30° C (59°–86° F). [See USP Controlled Room Temperature.]Dispense in light-resistant containers.Manufactured for: Pulaski, TN 38478Mfg. Rev. 04/12AV Rev. 02/13 (P)Store at 20°–25° C (68°–77° F); excursions permitted to 15°–30° C (59°–86° F). [See USP Controlled Room Temperature.]Dispense in light-resistant containers.Manufactured for: Pulaski, TN 38478Mfg. Rev. 04/12AV Rev. 02/13 (P)CONZIP (tramadol hydrochloride) capsules 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 68025-071-30 200 mg Capsules: White capsule imprinted with violet ink “G 253” on cap and “200” between lines on the body Bottle of 30 capsules: NDC 68025-072-30 300 mg Capsules: White capsule imprinted with red ink “G 254” on cap and “300” between lines on the body Bottle of 30 capsules: NDC 68025-073-30 Dispense in a tight container. Store at 20°C to 25°C (68°F to 77°F); excursions permitted to 15°C to 30°C (59°F to 86°F) . Keep out of reach of children. CONZIP (tramadol hydrochloride) capsules 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 68025-071-30 200 mg Capsules: White capsule imprinted with violet ink “G 253” on cap and “200” between lines on the body Bottle of 30 capsules: NDC 68025-072-30 300 mg Capsules: White capsule imprinted with red ink “G 254” on cap and “300” between lines on the body Bottle of 30 capsules: NDC 68025-073-30 Dispense in a tight container. Store at 20°C to 25°C (68°F to 77°F); excursions permitted to 15°C to 30°C (59°F to 86°F) . Keep out of reach of children. CONZIP (tramadol hydrochloride) capsules 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 68025-071-30 200 mg Capsules: White capsule imprinted with violet ink “G 253” on cap and “200” between lines on the body Bottle of 30 capsules: NDC 68025-072-30 300 mg Capsules: White capsule imprinted with red ink “G 254” on cap and “300” between lines on the body Bottle of 30 capsules: NDC 68025-073-30 Dispense in a tight container. Store at 20°C to 25°C (68°F to 77°F); excursions permitted to 15°C to 30°C (59°F to 86°F) . Keep out of reach of children. CONZIP (tramadol hydrochloride) capsules 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 68025-071-30 200 mg Capsules: White capsule imprinted with violet ink “G 253” on cap and “200” between lines on the body Bottle of 30 capsules: NDC 68025-072-30 300 mg Capsules: White capsule imprinted with red ink “G 254” on cap and “300” between lines on the body Bottle of 30 capsules: NDC 68025-073-30 Dispense in a tight container. Store at 20°C to 25°C (68°F to 77°F); excursions permitted to 15°C to 30°C (59°F to 86°F) . Keep out of reach of children. CONZIP (tramadol hydrochloride) capsules 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 68025-071-30 200 mg Capsules: White capsule imprinted with violet ink “G 253” on cap and “200” between lines on the body Bottle of 30 capsules: NDC 68025-072-30 300 mg Capsules: White capsule imprinted with red ink “G 254” on cap and “300” between lines on the body Bottle of 30 capsules: NDC 68025-073-30 Dispense in a tight container. Store at 20°C to 25°C (68°F to 77°F); excursions permitted to 15°C to 30°C (59°F to 86°F) . Keep out of reach of children. CONZIP (tramadol hydrochloride) capsules 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 68025-071-30 200 mg Capsules: White capsule imprinted with violet ink “G 253” on cap and “200” between lines on the body Bottle of 30 capsules: NDC 68025-072-30 300 mg Capsules: White capsule imprinted with red ink “G 254” on cap and “300” between lines on the body Bottle of 30 capsules: NDC 68025-073-30 Dispense in a tight container. Store at 20°C to 25°C (68°F to 77°F); excursions permitted to 15°C to 30°C (59°F to 86°F) . Keep out of reach of children. CONZIP (tramadol hydrochloride) capsules 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 68025-071-30 200 mg Capsules: White capsule imprinted with violet ink “G 253” on cap and “200” between lines on the body Bottle of 30 capsules: NDC 68025-072-30 300 mg Capsules: White capsule imprinted with red ink “G 254” on cap and “300” between lines on the body Bottle of 30 capsules: NDC 68025-073-30 Dispense in a tight container. Store at 20°C to 25°C (68°F to 77°F); excursions permitted to 15°C to 30°C (59°F to 86°F) . Keep out of reach of children. CONZIP (tramadol hydrochloride) capsules 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 68025-071-30 200 mg Capsules: White capsule imprinted with violet ink “G 253” on cap and “200” between lines on the body Bottle of 30 capsules: NDC 68025-072-30 300 mg Capsules: White capsule imprinted with red ink “G 254” on cap and “300” between lines on the body Bottle of 30 capsules: NDC 68025-073-30 Dispense in a tight container. Store at 20°C to 25°C (68°F to 77°F); excursions permitted to 15°C to 30°C (59°F to 86°F) . Keep out of reach of children.
Clinical Information
Chemical Structure
No Image foundClinical Pharmacology
CONZIP contains tramadol, an opioid agonist, and an inhibitor of reuptake of norepinephrine and serotonin. Although its mode of action is not completely understood, from animal tests, at least two complementary mechanisms appear applicable: binding of parent and M1 metabolite to μ-opioid receptors and weak inhibition of reuptake of norepinephrine and serotonin.
Opioid activity of tramadol is due to both low affinity binding of the parent compound and higher affinity binding of the O-demethylated metabolite M1 to μ-opioid receptors. In animal models, M1 is up to 6 times more potent than tramadol in producing analgesia and 200 times more potent in μ-opioid binding. Tramadol-induced analgesia is only partially antagonized by the opioid antagonist naloxone in several animal tests. The relative contribution of both tramadol and M1 to human analgesia is dependent upon the plasma concentrations of each compound.
Tramadol has been shown to inhibit reuptake of norepinephrine and serotonin , as have some other opioid analgesics. These mechanisms may contribute independently to the overall analgesic profile of tramadol. The relationship between exposure of tramadol and M1 and efficacy has not been evaluated in clinical studies.
Apart from analgesia, tramadol administration may produce a constellation of symptoms (including dizziness, somnolence, nausea, constipation, sweating and pruritus) similar to that of other opioids. In contrast to morphine, tramadol has not been shown to cause histamine release. At therapeutic doses, tramadol has no effect on heart rate, left ventricular function or cardiac index. Orthostatic hypotension has been observed.
Non-Clinical Toxicology
CONZIP is contraindicated for:CONZIP is also contraindicated in patients with:
Addiction, Abuse, and Misuse
CONZIP exposes patients and other users to the risks of opioid addiction, abuse, and misuse, which can lead to overdose and death. Assess each patient's risk prior to prescribing CONZIP and monitor all patients regularly for the development of these behaviors and conditions
[see Warnings and Precautions ()]
Life-Threatening Respiratory Depression
Serious, life-threatening, or fatal respiratory depression may occur with use of CONZIP. Monitor for respiratory depression, especially during initiation of CONZIP or following a dose increase. Instruct patients to swallow CONZIP capsules intact, and not to split, break, chew, crush, or dissolve the contents of the capsules to avoid exposure to a potentially fatal dose of tramadol
[see Warnings and Precautions ()].
Accidental Ingestion
Accidental ingestion of/exposure to even one dose of CONZIP especially by children, can result in a fatal overdose of tramadol
[see Warnings and Precautions ()]
Ultra-Rapid Metabolism Of Tramadol And Other Risk Factors For Life-Threatening Respiratory Depression In Children
Life-threatening respiratory depression and death have occurred in children who received tramadol. Some of the reported cases occurred following tonsillectomy and/or adenoidectomy, and at least one case, the child had evidence of being an ultra-rapid metabolizer of tramadol due to a CYP2D6 polymorphism
[see Warnings and Precautions ()]
. CONZIP is contraindicated in children younger than 12 years of age and in children younger than 18 years of age following tonsillectomy and/or adenoidectomy
[see Contraindications ()]
. Avoid the use of CONZIP in adolescents 12 to 18 years of age who have other risk factors that may increase their sensitivity to the respiratory depressant effects of tramadol
[see Warnings and Precautions ()].
Neonatal Opioid Withdrawal Syndrome
Prolonged use of CONZIP during pregnancy can result in neonatal opioid withdrawal syndrome, which may be life-threatening if not recognized and treated, and requires management according to protocols developed by neonatology experts. If opioid use is required for a prolonged period in a pregnant woman, advise the patient of the risk of neonatal opioid withdrawal syndrome and ensure that appropriate treatment will be available
[see Warnings and Precautions ()]
Interactions with Drugs Affecting Cytochrome P450 Isoenzymes
The effects of concomitant use or discontinuation of cytochrome P450 3A4 inducers, 3A4 inhibitors, or 2D6 inhibitors with tramadol are complex. Use of cytochrome P450 3A4 inducers, 3A4 inhibitors, or 2D6 inhibitors with CONZIP requires careful consideration of the effects on the parent drug, tramadol, and the active metabolite, M1
[see Warnings and Precautions (), Drug Interactions ()].
Risks From Concomitant Use With Benzodiazepines Or Other CNS Depressants
Concomitant use of opioids with benzodiazepines or other central nervous system (CNS) depressants, including alcohol, may result in profound sedation, respiratory depression, coma, and death
[
see
Warnings and Precautions (), Drug Interactions ()]
As with other drugs, the potential for interaction by a variety of mechanisms (e.g., pharmacodynamic, pharmacokinetic inhibition or enhancement, etc.) is a possibility (see ).
CONZIP contains tramadol, a Schedule IV controlled substance. As an opioid, CONZIP exposes users to the risks of addiction, abuse and misuse. Because extended-release products such as CONZIP deliver the opioid over an extended period of time, there is a greater risk for overdose and death due to the larger amount of tramadol present [
Although the risk of addiction in any individual is unknown, it can occur in patients appropriately prescribed CONZIP. Addiction can occur at recommended dosages and if the drug is misused or abused.
Assess each patient's risk for opioid addiction, abuse or misuse prior to prescribing CONZIP, and monitor all patients receiving CONZIP for the development of these behaviors and conditions. Risks are increased in patients with a personal or family history of substance abuse (including drug or alcohol abuse or addiction) or mental illness (e.g., major depression). The potential for these risks should not, however, prevent the proper management of pain in any given patient. Patients are increased risk may be prescribed opioids such as CONZIP, but use in such patients necessitates intensive counseling about the risks and proper use of CONZIP along with intensive monitoring for signs of addiction, abuse and misuse.
Abuse or misuse of CONZIP by splitting, breaking, chewing, crushing, snorting, or injecting the dissolved product will result in the uncontrolled delivery of tramadol and can result in overdose and death
Opioids are sought by drug abusers and people with addiction disorders and are subject to criminal diversion. Consider these risks when prescribing or dispense CONZIP. Strategies to reduce these risks include prescribing the drug in smallest appropriate quantity and advising the patient on the proper disposal of unused drug Contact local state professional licensing board or state controlled substances authority for information on how to prevent and detect abuse or diversion of this product.
The following serious or otherwise important adverse reactions are described in greater detail, in other sections:
Reference
This information is obtained from the National Institute of Health's Standard Packaging Label drug database.
"https://dailymed.nlm.nih.gov/dailymed/"
While we update our database periodically, we cannot guarantee it is always updated to the latest version.
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Clonazepam Description Each single-scored tablet, for oral administration, contains 0.5 mg, 1 mg, or 2 mg Clonazepam, USP, a benzodiazepine. Each tablet also contains corn starch, lactose monohydrate, magnesium stearate, microcrystalline cellulose, and povidone. Clonazepam tablets USP 0.5 mg contain Yellow D&C No. 10 Aluminum Lake. Clonazepam tablets USP 1 mg contain Yellow D&C No. 10 Aluminum Lake, as well as FD&C Blue No. 1 Aluminum Lake. Chemically, Clonazepam, USP is 5-(o-chlorophenyl)-1,3-dihydro-7-nitro-2H-1,4-benzodiazepin-2-one. It is a light yellow crystalline powder. It has the following structural formula: C15H10ClN3O3 M.W. 315.72Tips
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Interactions
Interactions
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