Tramadol Hcl
Generic Name: tramadol hcl
Brand Names:
Tramadol Hcl
11. Description Tramadol hydrochloride tablets, USP, for oral use, are an opioid agonist. The chemical name for tramadol hydrochloride is (±)cis-2-[(dimethylamino)methyl]-1-(3-methoxyphenyl) cyclohexanol hydrochloride. The structural formula is: The molecular weight of tramadol hydrochloride is 299.8. Tramadol hydrochloride, USP is a white, bitter, crystalline and odorless powder. It is readily soluble in water and ethanol and has a pKa of 9.41.
Overview
11. Description Tramadol hydrochloride tablets, USP, for oral use, are an opioid agonist. The chemical name for tramadol hydrochloride is (±)cis-2-[(dimethylamino)methyl]-1-(3-methoxyphenyl) cyclohexanol hydrochloride. The structural formula is: The molecular weight of tramadol hydrochloride is 299.8. Tramadol hydrochloride, USP is a white, bitter, crystalline and odorless powder. It is readily soluble in water and ethanol and has a pKa of 9.41.
Uses
1. Indications and Usage 1 INDICATIONS AND USAGE Tramadol hydrochloride tablets are indicated in adults for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate. Limitations of Use Because of the risks of addiction, abuse, and misuse with opioids, even at recommended doses [see WARNINGS AND PRECAUTIONS (5.1)], reserve tramadol hydrochloride tablets for use in patients for whom alternative treatment options [e.g., non-opioid analgesics]: • Have not been tolerated or are not expected to be tolerated. • Have not provided adequate analgesia or are not expected to provide adequate analgesia.
Dosage
2. Dosage and Administration 2.1 Important Dosage and Administration Instructions • Do not use tramadol hydrochloride tablets concomitantly with other tramadol-containing products. • Do not administer tramadol hydrochloride tablets at a dose exceeding 400 mg per day. • Use the lowest effective dosage for the shortest duration consistent with individual patient treatment goals [SEE WARNINGS AND PRECAUTIONS (5.1)]. • Initiate the dosing regimen for each patient individually, taking into account the patient's severity of pain, patient response, prior analgesic treatment experience, and risk factors for addiction, abuse, and misuse [SEE WARNINGS AND PRECAUTIONS (5.1)].
Side Effects
6. Adverse Reactions Section The following serious adverse reactions are described, or described in greater detail, in other sections: Addiction, Abuse, and Misuse [SEE WARNINGS AND PRECAUTIONS (5.1)] Life Threatening Respiratory Depression [SEE WARNINGS AND PRECAUTIONS (5.3)] Ultra-Rapid Metabolism of Tramadol and Other Risk Factors for Life-threatening Respiratory Depression in CHILDREN [SEE WARNINGS AND PRECAUTIONS (5.4)] Neonatal Opioid Withdrawal Syndrome [SEE WARNINGS AND PRECAUTIONS (5.5)] Interactions with Benzodiazepines or Other CNS Depressants [SEE WARNINGS AND PRECAUTIONS (5.7)] Serotonin Syndrome [SEE WARNINGS AND PRECAUTIONS (5.8)] Seizures [SEE WARNINGS AND PRECAUTIONS (5.9)] Suicide [SEE WARNINGS AND PRECAUTIONS (5.10)] Adrenal Insufficiency [SEE WARNINGS AND PRECAUTIONS (5...
Interactions
7. Drug Interactions Table 2: Clinically Significant Drug Interactions with Tramadol Hydrochloride Tablets Inhibitors of CYP2D6 Clinical Impact: The concomitant use of tramadol hydrochloride tablets and CYP2D6 inhibitors may result in an increase in the plasma concentration of tramadol and a decrease in the plasma concentration of M1, particularly when an inhibitor is added after a stable dose of tramadol hydrochloride tablets is achieved. Since M1 is a more potent µ-opioid agonist, decreased M1 exposure could result in decreased therapeutic effects, and may result in signs and symptoms of opioid withdrawal in patients who had developed physical dependence to tramadol.
Warnings
Boxed Warning WARNING: ADDICTION, ABUSE, AND MISUSE; RISK EVALUATION AND MITIGATION STRATEGY(REMS); LIFE-THREATENING RESPIRATORY DEPRESSION; ACCIDENTAL INGESTION; ULTRA-RAPID METABOLISM OF TRAMADOL AND OTHER RISK FACTORS FOR LIFE THREATENING RESPIRATORY DEPRESSION IN CHILDREN; NEONATAL OPIOID WITHDRAWAL SYNDROME; INTERACTIONS WITH DRUGS AFFECTING CYTOCHROME P450 ISOENZYMES; AND RISKS FROM CONCOMITANT USE WITH BENZODIAZEPINES OR OTHER CNS DEPRESSANTS ADDICTION, ABUSE AND MISUSE Tramadol hydrochlo... 5. Warnings and Precautions 5.1 Addiction, Abuse and Misuse Tramadol hydrochloride tablets contain tramadol, a Schedule IV controlled substance. As an opioid, tramadol hydrochloride tablets expose users to the risks of addiction, abuse, and misuse [SEE DRUG ABUSE AND DEPENDENCE (9)]. Although the risk of addiction in any individual is unknown, it can occur in patients appropriately prescribed tramadol hydrochloride tablets. 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 tramadol hydrochloride tablets, and monitor all patients receiving tramadol hydrochloride tablets for the development of these behaviors and conditions. 4. Contraindications Tramadol hydrochloride tablets are contraindicated for: • all children younger than 12 years of age [SEE WARNINGS AND PRECAUTIONS (5.4)]. • postoperative management in children younger than 18 years of age following tonsillectomy and/or adenoidectomy [SEE WARNINGS AND PRECAUTIONS (5.4)].
Storage
16. How Supplied/Storage and Handling Tramadol hydrochloride tablets, USP, 50 mg are available as white capsule shaped film coated tablets, debossed with “377” on one side and plain on the other side. Bottles of 30 Tablets NDC: 80425-0058-01 Bottles of 60 Tablets NDC: 80425-0058-02 Dispense in a tight container.
Frequently Asked Questions
What is Tramadol Hcl used for?▼
1. Indications and Usage 1 INDICATIONS AND USAGE Tramadol hydrochloride tablets are indicated in adults for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate. Limitations of Use Because of the risks of addiction, abuse, and misuse with opioids, even at recommended doses [see WARNINGS AND PRECAUTIONS (5.1)], reserve tramadol hydrochloride tablets for use in patients for whom alternative treatment options [e.g., non-opioid analgesics]: • Have not been tolerated or are not expected to be tolerated. • Have not provided adequate analgesia or are not expected to provide adequate analgesia.
What are the side effects of Tramadol Hcl?▼
6. Adverse Reactions Section The following serious adverse reactions are described, or described in greater detail, in other sections: Addiction, Abuse, and Misuse [SEE WARNINGS AND PRECAUTIONS (5.1)] Life Threatening Respiratory Depression [SEE WARNINGS AND PRECAUTIONS (5.3)] Ultra-Rapid Metabolism of Tramadol and Other Risk Factors for Life-threatening Respiratory Depression in CHILDREN [SEE WARNINGS AND PRECAUTIONS (5.4)] Neonatal Opioid Withdrawal Syndrome [SEE WARNINGS AND PRECAUTIONS (5.5)] Interactions with Benzodiazepines or Other CNS Depressants [SEE WARNINGS AND PRECAUTIONS (5.7)] Serotonin Syndrome [SEE WARNINGS AND PRECAUTIONS (5.8)] Seizures [SEE WARNINGS AND PRECAUTIONS (5.9)] Suicide [SEE WARNINGS AND PRECAUTIONS (5.10)] Adrenal Insufficiency [SEE WARNINGS AND PRECAUTIONS (5...
What are the important warnings for Tramadol Hcl?▼
Boxed Warning WARNING: ADDICTION, ABUSE, AND MISUSE; RISK EVALUATION AND MITIGATION STRATEGY(REMS); LIFE-THREATENING RESPIRATORY DEPRESSION; ACCIDENTAL INGESTION; ULTRA-RAPID METABOLISM OF TRAMADOL AND OTHER RISK FACTORS FOR LIFE THREATENING RESPIRATORY DEPRESSION IN CHILDREN; NEONATAL OPIOID WITHDRAWAL SYNDROME; INTERACTIONS WITH DRUGS AFFECTING CYTOCHROME P450 ISOENZYMES; AND RISKS FROM CONCOMITANT USE WITH BENZODIAZEPINES OR OTHER CNS DEPRESSANTS ADDICTION, ABUSE AND MISUSE Tramadol hydrochlo... 5. Warnings and Precautions 5.1 Addiction, Abuse and Misuse Tramadol hydrochloride tablets contain tramadol, a Schedule IV controlled substance. As an opioid, tramadol hydrochloride tablets expose users to the risks of addiction, abuse, and misuse [SEE DRUG ABUSE AND DEPENDENCE (9)]. Although the risk of addiction in any individual is unknown, it can occur in patients appropriately prescribed tramadol hydrochloride tablets. 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 tramadol hydrochloride tablets, and monitor all patients receiving tramadol hydrochloride tablets for the development of these behaviors and conditions. 4. Contraindications Tramadol hydrochloride tablets are contraindicated for: • all children younger than 12 years of age [SEE WARNINGS AND PRECAUTIONS (5.4)]. • postoperative management in children younger than 18 years of age following tonsillectomy and/or adenoidectomy [SEE WARNINGS AND PRECAUTIONS (5.4)].
Related Medications
Menthol, Capsaicin
menthol, capsaicin
External Analgesic
Fucus Vesiculosus, Spongia Tosta, Glandula Suprarenalis Suis, Hypophysis Suis, Thyroidinum (suis), Bromium, Calcarea Carbonica, Graphites, Iodium, Lachesis Mutus, Levothyroxinum, Pulsatilla (pratensis), Selenium Metallicum
fucus vesiculosus, spongia tosta, glandula suprarenalis suis, hypophysis suis, thyroidinum (suis), bromium, calcarea carbonica, graphites, iodium, lachesis mutus, levothyroxinum, pulsatilla (pratensis), selenium metallicum
l-Thyroxine [EPC]
PURPOSE: Bromium – neck swelling,** Calcarea Carbonica 12X - constipation,** Glandula Suprarenalis Suis - fatigue,** Graphites – dry skin,** Hypophysis Suis – heavy menses,** Iodium - forgetfulness,** Lachesis Mutus - insomnia,** Levothyroxinum - chilliness,** Pulsatilla - sadness,** Selenium Metallicum – hair loss,** Thyroidinum - edema,** Fucus Vesiculosus – weight gain,** Spongia Tosta - soreness.** **Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA eva
Aconitum Nap., Arnica, Arsenicum Alb., Baptisia, Belladonna, Bryonia, Calendula, Chamomilla, Chelidonium Majus, Crotalus Horridus, Gelsemium, Hepar Sulph. Calc., Kreosotum, Merc. Viv., Myrrha, Nux Vom., Phosphorus, Phytolacca, Plantago, Rhus Toxicodendron, Silicea, Staphysag., Echinacea
aconitum nap., arnica, arsenicum alb., baptisia, belladonna, bryonia, calendula, chamomilla, chelidonium majus, crotalus horridus, gelsemium, hepar sulph. calc., kreosotum, merc. viv., myrrha, nux vom., phosphorus, phytolacca, plantago, rhus toxicodendron, silicea, staphysag., echinacea
Non-Standardized Plant Allergenic Extract [EPC]
OTC - PURPOSE SECTION Formulated for symptoms associated peridontal conditions such as gingivitis, halitosis, teeth pain and gum sensitivity.
Medical Disclaimer
This drug information is for educational purposes only and should not replace professional medical advice. Drug information is sourced from the FDA National Drug Code Directory and Structured Product Labeling. Always consult with a healthcare provider before starting, stopping, or changing any medication.