Tramadol Hydrochloride

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Overview

What is Tramadol Hydrochloride?

Tramadol hydrochloride tablets is a centrally acting analgesic. The chemical name for tramadol hydrochloride is (±)cis-2-[(dimethylamino)methyl]-1-(3methoxyphenyl) cyclohexanol hydrochloride. Its structural formula is:

The molecular formula of tramadol hydrochloride is CHNO•HCl and its molecular weight is 299.8.

Tramadol hydrochloride is a white, bitter, crystalline and odorless powder. It 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.

Each tramadol hydrochloride tablet intended for oral administration contains 50 mg of tramadol hydrochloride. In addition, it also contains the following inactive ingredients: hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80, pregelatinized starch, sodium starch glycolate, and titanium dioxide.

What does Tramadol Hydrochloride look like?

What are the available doses of Tramadol Hydrochloride?

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What should I talk to my health care provider before I take Tramadol Hydrochloride?

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How should I use Tramadol Hydrochloride?

Tramadol hydrochloride is indicated for the management of moderate to moderately severe pain in adults.

For patients with moderate to moderately severe chronic pain not requiring rapid onset of analgesic effect, the tolerability of tramadol hydrochloride tablets can be improved by initiating therapy with the following titration regimen: tramadol hydrochloride tablets should be started at 25 mg/day qAM and titrated in 25 mg increments as separate doses every 3 days to reach 100 mg/day (25 mg q.i.d.). Thereafter the total daily dose may be increased by 50 mg as tolerated every 3 days to reach 200 mg/day (50 mg q.i.d.). After titration, tramdol hydrochloride tablets 50 to 100 mg can be administered as needed for pain relief every 4 to 6 hours

For the subset of patients for whom rapid onset of analgesic effect is required and for whom the benefits outweigh the risk of discontinuation due to adverse events associated with higher initial doses, tramdol hydrochloride tablets 50 mg to 100 mg can be administered as needed for pain relief every four to six hours,

What interacts with Tramadol Hydrochloride?

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What are the warnings of Tramadol Hydrochloride?

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What are the precautions of Tramadol Hydrochloride?

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What are the side effects of Tramadol Hydrochloride?

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What should I look out for while using Tramadol Hydrochloride?

Tramadol hydrochloride should not be administered to patients who have previously demonstrated hypersensitivity to tramadol, any other component of this product or opioids. Tramadol hydrochloride is contraindicated in any situation where opioids are contraindicated, including acute intoxication with any of the following: alcohol, hypnotics, narcotics, centrally acting analgesics, opioids or psychotropic drugs. Tramadol hydrochloride may worsen central nervous system and respiratory depression in these patients.

What might happen if I take too much Tramadol Hydrochloride?

Acute overdosage with tramadol can be manifested by respiratory depression, somnolence progressing to stupor or coma, skeletal muscle flaccidity, cold and clammy skin, constricted pupils, seizures, bradycardia, hypotension, cardiac arrest, and death. Deaths due to overdose have been reported with abuse and misuse of tramadol (see ). Review of case reports has indicated that the risk of fatal overdose is further increased when tramadol is abused concurrently with alcohol or other CNS depressants, including other opioids.

In the treatment of tramadol overdosage, primary attention should be given to the reestablishment of a patent airway and institution of assisted or controlled ventilation. Supportive measures (including oxygen and vasopressors) should be employed in the management of circulatory shock and pulmonary edema accompanying overdose as indicated. Cardiac arrest or arrhythmias may require cardiac massage or defibrillation.

While naloxone will reverse some, but not all, symptoms caused by overdosage with tramadol, the risk of seizures is also increased with naloxone administration. In animals convulsions following the administration of toxic doses of tramadol hydrochloride tablets could be suppressed with barbiturates or benzodiazepines but were increased with naloxone. Naloxone administration did not change the lethality of an overdose in mice. Hemodialysis is not expected to be helpful in an overdose because it removes less than 7% of the administered dose in a 4-hour dialysis period.

How should I store and handle Tramadol Hydrochloride?

GEODON for Injection should be stored at 25°C (77°F); excursions permitted to 15–30°C (59–86°F) [See USP Controlled Room Temperature] in dry form. Protect from light. Following reconstitution, GEODON for Injection can be stored, when protected from light, for up to 24 hours at 15°–30°C (59°–86°F) or up to 7 days refrigerated, 2°–8°C (36°–46°F).Tramadol hydrochloride tablets are supplied as unscored, white, round film coated tablets debossed “AN” over “627”.They are supplied as follows:Blisters of 30 & 60 tabletsDispense in a tight container as defined in the USP.Store at 25°C (77°F); excursions permitted to 15 - 30°C (59 – 86°F).Manufactured by:Amneal PharmaceuticalsPaterson, New Jersey 07504Amneal PharmaceuticalsHauppauge, NY 11788Distributed by:Amneal PharmaceuticalsGlasgow, KY 42164Rev. 11-2009Repackaged by: Contract Pharmacy Services-PA125 Titus Ave Suite 200Warrington, PA 18976 USAOriginal--02/2010--NJWUpdated--08/2010--NJWTramadol hydrochloride tablets are supplied as unscored, white, round film coated tablets debossed “AN” over “627”.They are supplied as follows:Blisters of 30 & 60 tabletsDispense in a tight container as defined in the USP.Store at 25°C (77°F); excursions permitted to 15 - 30°C (59 – 86°F).Manufactured by:Amneal PharmaceuticalsPaterson, New Jersey 07504Amneal PharmaceuticalsHauppauge, NY 11788Distributed by:Amneal PharmaceuticalsGlasgow, KY 42164Rev. 11-2009Repackaged by: Contract Pharmacy Services-PA125 Titus Ave Suite 200Warrington, PA 18976 USAOriginal--02/2010--NJWUpdated--08/2010--NJWTramadol hydrochloride tablets are supplied as unscored, white, round film coated tablets debossed “AN” over “627”.They are supplied as follows:Blisters of 30 & 60 tabletsDispense in a tight container as defined in the USP.Store at 25°C (77°F); excursions permitted to 15 - 30°C (59 – 86°F).Manufactured by:Amneal PharmaceuticalsPaterson, New Jersey 07504Amneal PharmaceuticalsHauppauge, NY 11788Distributed by:Amneal PharmaceuticalsGlasgow, KY 42164Rev. 11-2009Repackaged by: Contract Pharmacy Services-PA125 Titus Ave Suite 200Warrington, PA 18976 USAOriginal--02/2010--NJWUpdated--08/2010--NJWTramadol hydrochloride tablets are supplied as unscored, white, round film coated tablets debossed “AN” over “627”.They are supplied as follows:Blisters of 30 & 60 tabletsDispense in a tight container as defined in the USP.Store at 25°C (77°F); excursions permitted to 15 - 30°C (59 – 86°F).Manufactured by:Amneal PharmaceuticalsPaterson, New Jersey 07504Amneal PharmaceuticalsHauppauge, NY 11788Distributed by:Amneal PharmaceuticalsGlasgow, KY 42164Rev. 11-2009Repackaged by: Contract Pharmacy Services-PA125 Titus Ave Suite 200Warrington, PA 18976 USAOriginal--02/2010--NJWUpdated--08/2010--NJWTramadol hydrochloride tablets are supplied as unscored, white, round film coated tablets debossed “AN” over “627”.They are supplied as follows:Blisters of 30 & 60 tabletsDispense in a tight container as defined in the USP.Store at 25°C (77°F); excursions permitted to 15 - 30°C (59 – 86°F).Manufactured by:Amneal PharmaceuticalsPaterson, New Jersey 07504Amneal PharmaceuticalsHauppauge, NY 11788Distributed by:Amneal PharmaceuticalsGlasgow, KY 42164Rev. 11-2009Repackaged by: Contract Pharmacy Services-PA125 Titus Ave Suite 200Warrington, PA 18976 USAOriginal--02/2010--NJWUpdated--08/2010--NJWTramadol hydrochloride tablets are supplied as unscored, white, round film coated tablets debossed “AN” over “627”.They are supplied as follows:Blisters of 30 & 60 tabletsDispense in a tight container as defined in the USP.Store at 25°C (77°F); excursions permitted to 15 - 30°C (59 – 86°F).Manufactured by:Amneal PharmaceuticalsPaterson, New Jersey 07504Amneal PharmaceuticalsHauppauge, NY 11788Distributed by:Amneal PharmaceuticalsGlasgow, KY 42164Rev. 11-2009Repackaged by: Contract Pharmacy Services-PA125 Titus Ave Suite 200Warrington, PA 18976 USAOriginal--02/2010--NJWUpdated--08/2010--NJWTramadol hydrochloride tablets are supplied as unscored, white, round film coated tablets debossed “AN” over “627”.They are supplied as follows:Blisters of 30 & 60 tabletsDispense in a tight container as defined in the USP.Store at 25°C (77°F); excursions permitted to 15 - 30°C (59 – 86°F).Manufactured by:Amneal PharmaceuticalsPaterson, New Jersey 07504Amneal PharmaceuticalsHauppauge, NY 11788Distributed by:Amneal PharmaceuticalsGlasgow, KY 42164Rev. 11-2009Repackaged by: Contract Pharmacy Services-PA125 Titus Ave Suite 200Warrington, PA 18976 USAOriginal--02/2010--NJWUpdated--08/2010--NJWTramadol hydrochloride tablets are supplied as unscored, white, round film coated tablets debossed “AN” over “627”.They are supplied as follows:Blisters of 30 & 60 tabletsDispense in a tight container as defined in the USP.Store at 25°C (77°F); excursions permitted to 15 - 30°C (59 – 86°F).Manufactured by:Amneal PharmaceuticalsPaterson, New Jersey 07504Amneal PharmaceuticalsHauppauge, NY 11788Distributed by:Amneal PharmaceuticalsGlasgow, KY 42164Rev. 11-2009Repackaged by: Contract Pharmacy Services-PA125 Titus Ave Suite 200Warrington, PA 18976 USAOriginal--02/2010--NJWUpdated--08/2010--NJWTramadol hydrochloride tablets are supplied as unscored, white, round film coated tablets debossed “AN” over “627”.They are supplied as follows:Blisters of 30 & 60 tabletsDispense in a tight container as defined in the USP.Store at 25°C (77°F); excursions permitted to 15 - 30°C (59 – 86°F).Manufactured by:Amneal PharmaceuticalsPaterson, New Jersey 07504Amneal PharmaceuticalsHauppauge, NY 11788Distributed by:Amneal PharmaceuticalsGlasgow, KY 42164Rev. 11-2009Repackaged by: Contract Pharmacy Services-PA125 Titus Ave Suite 200Warrington, PA 18976 USAOriginal--02/2010--NJWUpdated--08/2010--NJWTramadol hydrochloride tablets are supplied as unscored, white, round film coated tablets debossed “AN” over “627”.They are supplied as follows:Blisters of 30 & 60 tabletsDispense in a tight container as defined in the USP.Store at 25°C (77°F); excursions permitted to 15 - 30°C (59 – 86°F).Manufactured by:Amneal PharmaceuticalsPaterson, New Jersey 07504Amneal PharmaceuticalsHauppauge, NY 11788Distributed by:Amneal PharmaceuticalsGlasgow, KY 42164Rev. 11-2009Repackaged by: Contract Pharmacy Services-PA125 Titus Ave Suite 200Warrington, PA 18976 USAOriginal--02/2010--NJWUpdated--08/2010--NJWTramadol hydrochloride tablets are supplied as unscored, white, round film coated tablets debossed “AN” over “627”.They are supplied as follows:Blisters of 30 & 60 tabletsDispense in a tight container as defined in the USP.Store at 25°C (77°F); excursions permitted to 15 - 30°C (59 – 86°F).Manufactured by:Amneal PharmaceuticalsPaterson, New Jersey 07504Amneal PharmaceuticalsHauppauge, NY 11788Distributed by:Amneal PharmaceuticalsGlasgow, KY 42164Rev. 11-2009Repackaged by: Contract Pharmacy Services-PA125 Titus Ave Suite 200Warrington, PA 18976 USAOriginal--02/2010--NJWUpdated--08/2010--NJWTramadol hydrochloride tablets are supplied as unscored, white, round film coated tablets debossed “AN” over “627”.They are supplied as follows:Blisters of 30 & 60 tabletsDispense in a tight container as defined in the USP.Store at 25°C (77°F); excursions permitted to 15 - 30°C (59 – 86°F).Manufactured by:Amneal PharmaceuticalsPaterson, New Jersey 07504Amneal PharmaceuticalsHauppauge, NY 11788Distributed by:Amneal PharmaceuticalsGlasgow, KY 42164Rev. 11-2009Repackaged by: Contract Pharmacy Services-PA125 Titus Ave Suite 200Warrington, PA 18976 USAOriginal--02/2010--NJWUpdated--08/2010--NJWTramadol hydrochloride tablets are supplied as unscored, white, round film coated tablets debossed “AN” over “627”.They are supplied as follows:Blisters of 30 & 60 tabletsDispense in a tight container as defined in the USP.Store at 25°C (77°F); excursions permitted to 15 - 30°C (59 – 86°F).Manufactured by:Amneal PharmaceuticalsPaterson, New Jersey 07504Amneal PharmaceuticalsHauppauge, NY 11788Distributed by:Amneal PharmaceuticalsGlasgow, KY 42164Rev. 11-2009Repackaged by: Contract Pharmacy Services-PA125 Titus Ave Suite 200Warrington, PA 18976 USAOriginal--02/2010--NJWUpdated--08/2010--NJWTramadol hydrochloride tablets are supplied as unscored, white, round film coated tablets debossed “AN” over “627”.They are supplied as follows:Blisters of 30 & 60 tabletsDispense in a tight container as defined in the USP.Store at 25°C (77°F); excursions permitted to 15 - 30°C (59 – 86°F).Manufactured by:Amneal PharmaceuticalsPaterson, New Jersey 07504Amneal PharmaceuticalsHauppauge, NY 11788Distributed by:Amneal PharmaceuticalsGlasgow, KY 42164Rev. 11-2009Repackaged by: Contract Pharmacy Services-PA125 Titus Ave Suite 200Warrington, PA 18976 USAOriginal--02/2010--NJWUpdated--08/2010--NJWTramadol hydrochloride tablets are supplied as unscored, white, round film coated tablets debossed “AN” over “627”.They are supplied as follows:Blisters of 30 & 60 tabletsDispense in a tight container as defined in the USP.Store at 25°C (77°F); excursions permitted to 15 - 30°C (59 – 86°F).Manufactured by:Amneal PharmaceuticalsPaterson, New Jersey 07504Amneal PharmaceuticalsHauppauge, NY 11788Distributed by:Amneal PharmaceuticalsGlasgow, KY 42164Rev. 11-2009Repackaged by: Contract Pharmacy Services-PA125 Titus Ave Suite 200Warrington, PA 18976 USAOriginal--02/2010--NJWUpdated--08/2010--NJWTramadol hydrochloride tablets are supplied as unscored, white, round film coated tablets debossed “AN” over “627”.They are supplied as follows:Blisters of 30 & 60 tabletsDispense in a tight container as defined in the USP.Store at 25°C (77°F); excursions permitted to 15 - 30°C (59 – 86°F).Manufactured by:Amneal PharmaceuticalsPaterson, New Jersey 07504Amneal PharmaceuticalsHauppauge, NY 11788Distributed by:Amneal PharmaceuticalsGlasgow, KY 42164Rev. 11-2009Repackaged by: Contract Pharmacy Services-PA125 Titus Ave Suite 200Warrington, PA 18976 USAOriginal--02/2010--NJWUpdated--08/2010--NJWTramadol hydrochloride tablets are supplied as unscored, white, round film coated tablets debossed “AN” over “627”.They are supplied as follows:Blisters of 30 & 60 tabletsDispense in a tight container as defined in the USP.Store at 25°C (77°F); excursions permitted to 15 - 30°C (59 – 86°F).Manufactured by:Amneal PharmaceuticalsPaterson, New Jersey 07504Amneal PharmaceuticalsHauppauge, NY 11788Distributed by:Amneal PharmaceuticalsGlasgow, KY 42164Rev. 11-2009Repackaged by: Contract Pharmacy Services-PA125 Titus Ave Suite 200Warrington, PA 18976 USAOriginal--02/2010--NJWUpdated--08/2010--NJW

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Clinical Information

Chemical Structure

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Clinical Pharmacology

Tramadol Hydrochloride contains tramadol, a centrally acting synthetic opioid analgesic. 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 re-uptake of norepinephrine and serotonin.

Opioid activity 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 opiate 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 (see ).

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 hydrochloride. Analgesia in humans begins approximately within one hour after administration and reaches a peak in approximately two to three hours.

Apart from analgesia, tramadol hydrochloride 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 hydrochloride has no effect on heart rate, left-ventricular function or cardiac index. Orthostatic hypotension has been observed.

Non-Clinical Toxicology

Tramadol hydrochloride should not be administered to patients who have previously demonstrated hypersensitivity to tramadol, any other component of this product or opioids. Tramadol hydrochloride is contraindicated in any situation where opioids are contraindicated, including acute intoxication with any of the following: alcohol, hypnotics, narcotics, centrally acting analgesics, opioids or psychotropic drugs. Tramadol hydrochloride may worsen central nervous system and respiratory depression in these patients.

The administration of tramadol hydrochloride may complicate the clinical assessment of patients with acute abdominal conditions.

Tramadol hydrochloride was administered to 550 patients during the double-blind or open-label extension periods in U.S. studies of chronic nonmalignant pain. Of these patients, 375 were 65 years old or older. Table 2 reports the cumulative incidence rate of adverse reactions by 7, 30 and 90 days for the most frequent reactions (5% or more by 7 days). The most frequently reported events were in the central nervous system and gastrointestinal system. Although the reactions listed in the table are felt to be probably related to tramadol hydrochloride administration, the reported rates also include some events that may have been due to underlying disease or concomitant medication. The overall incidence rates of adverse experiences in these trials were similar for tramadol hydrochloride and the active control groups, TYLENOL® with Codeine #3 (acetaminophen 300 mg with codeine phosphate 30 mg), and aspirin 325 mg with codeine phosphate 30 mg, however, the rates of withdrawals due to adverse events appeared to be higher in the tramadol hydrochloride groups.

Table 2: Cumulative Incidence of Adverse Reactions for Tramadol Hydrochloride in Chronic Trials of Nonmalignant Pain (N=427)

Incidence 1% to less than 5% possibly causally related:

Body as a Whole:

Cardiovascular:

Central Nervous System:

Miosis, Nervousness, Sleep disorder.

Gastrointestinal:

Musculoskeletal:

Skin:

Special Senses:

Urogenital:

Incidence less than 1%, possibly causally related:

Body as a Whole:

Cardiovascular:

Central Nervous System:

Respiratory:

Skin:

Special Senses:

Urogenital:

Other adverse experiences, causal relationship unknown:

Cardiovascular:

Central Nervous System:

Gastrointestinal:

Laboratory Abnormalities:

Sensory:

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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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Review

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Professional

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. 315.72

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Interactions

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