Tramadol Hydrochloride (Tramadol Hydrochloride)

Trade Name : Tramadol Hydrochloride

Teva Pharmaceuticals USA, Inc.

TABLET, FILM COATED

Strength 50 mg/1

TRAMADOL HYDROCHLORIDE Full Opioid Agonists [MoA],Opioid Agonist [EPC]

Delivery Process

Submit a Request

You can fill in a request for your medicine through the form provided. You can access the form by clicking on the ‘Get Price’ button.

We’ll Get in Touch

Once we review your request, we’ll send you an estimated price for the medicine within 2-5 days.

Confirmation and Payment

You can fill in a request for your medicine through the form provided. You can access the form by clicking on the ‘Get Price’ button.

Submit a Request

You can fill in a request for your medicine through the form provided. You can access the form by clicking on the ‘Get Price’ button.

Product information is meant for

Wholesalers Suppliers Exporters Doctors MOH Tender Supplies Hospitals Brand CROs Comparator Supplies Generic Cooperate Sourcing Individual Patients Indian Institutional Buyers

Disclaimer

Trade Marks displayed in compliance with provisions of: Trademark Act, 1999 u/s 30 and 30 (1) of "Fair use"

GNH India is WHO GDP and ISO 9001 2015 Certified Pharmaceutical Wholesaler/ Supplier/ Exporters/ Importer from India of Tramadol Hydrochloride (Tramadol Hydrochloride) which is also known as Tramadol Hydrochloride and Manufactured by Teva Pharmaceuticals USA, Inc.. It is available in strength of 50 mg/1 per ml. Read more

Tramadol Hydrochloride (Tramadol Hydrochloride) is supplied for Tenders/ Emergency imports/ Un - licensed, Specials, Orphan drug/ Name patient line/ RLD supplies/ Reference listed drugs/ Comparator Drug/ Bio-Similar/ Innovator samples For Clinical trials.  Click to know price.     Read less

Packaging and Delivery

Validated Cold Chain Shipment

We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

Inquire directly from our website and get 5% off on any medicine!

We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

Read more

About GNH

We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

Read more
  • No data
  • Arrayn- ADDICTION, ABUSE AND MISUSE
  • Tramadol hydrochloride tablets expose patients and other users to the risks of opioid addiction, abuse and misuse, which can lead to overdose and death. Assess each patientu2019s risk prior to prescribing tramadol hydrochloride tablets, and monitor all patients regularly for the development of these behaviors and conditions .
  • Arrayn- OPIOID ANALGESIC RISK EVALUATION AND MITIGATION STRATEGY (REMS)
  • To ensure that the benefits of opioid analgesics outweigh the risks of addiction, abuse, and misuse, the Food and Drug Administration (FDA) has required a REMS for these products . Under the requirements of the REMS, drug companies with approved opioid analgesic products must make REMS-compliant education programs available to healthcare providers. Healthcare providers are strongly encouraged to
  • Arrayn- LIFE-THREATENING RESPIRATORY DEPRESSION
  • Serious, life-threatening, or fatal respiratory depression may occur with use of tramadol hydrochloride tablets. Monitor for respiratory depression, especially during initiation of tramadolu00a0hydrochloride tablets or following a dose increase n
  • Arrayn- ACCIDENTAL INGESTION
  • Accidental ingestion of tramadol hydrochloride tablets, especially by children, can be fatal .
  • Arrayn- Array
  • Life-threatening respiratory depression and death have occurred in children who received n- tramadol. Some of the reported cases followed tonsillectomy and/or adenoidectomy; in at least one case, the child had evidence of being an ultra-rapid metabolizer of tramadol due to a CYP2D6 polymorphism . Tramadolu00a0hydrochloride tablets are contraindicated in children younger than 12 years of age and in children younger than 18 years of age following tonsillectomy and/or adenoidectomy . Avoid the use of tramadolu00a0hydrochloride tablets 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 .
  • Arrayn- NEONATAL OPIOID WITHDRAWAL SYNDROME
  • Prolonged use of tramadolu00a0hydrochloride tablets 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 .
  • Arrayn- 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 tramadolu00a0hydrochloride tablets requires careful consideration of the effects on the parent drug, tramadol, and the active metabolite, M1 .
  • Arrayn- Array
  • 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 .
  • 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-THREATENINGu00a0 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
  • See full prescribing information for complete boxed warning.
  • Tramadol expose users to the risks of addiction, abuse and misuse, which can lead to overdose and death. Assess each patientu2019s risk prior to prescribing tramadol , and monitor regularly for these behaviors or conditions. ()
  • To ensure that the benefits of opioid analgesics outweigh the risks of addiction, abuse, and misuse, the Food and Drug Administration (FDA) has required a Risk Evaluation and Mitigation Strategy (REMS) for these products. ()
  • Serious, life-threatening, or fatal respiratory depression may occur.n n- Monitor closely, especially during initiation or following a dose increase. ()
  • Accidental ingestion of tramadol , especially by children, can result in a fatal overdose of tramadol. ()
  • Life-threatening respiratory depression and death have occurred in children who received tramadol. Some of the reported cases followed tonsillectomy and/or adenoidectomy; in at least one case, the child had evidence of being an ultra-rapid metabolizer of tramadol due to a CYP2D6 polymorphism. ()
  • Tramadol u00a0contraindicated in children younger than 12 years of age and in children younger than 18 years of age following tonsillectomy and/or adenoidectomy (). Avoid the use of tramadol n adolescents 12 to 18 years of age who have other risk factors that may increase their sensitivity to the respiratory depressant effects of tramadol. ()
  • Prolonged use of tramadol , during pregnancy can result in neonatal opioid withdrawal syndrome, which may be life threatening if not recognized and treated. If prolonged opioid use is required in a pregnant woman, advise the patient of the risk of neonatal opioid withdrawal syndrome and ensure that appropriate treatment will be available. ()
  • 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 tramadol requires careful consideration of the effects on the parent drug, tramadol, and the active metabolite, M1. (, )
  • Arrayn- 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. Reserve concomitant prescribing for use in patients for whom alternative treatment options are inadequate; limit dosages and durations to the minimum required; and follow patients for signs and symptoms of respiratory depression and sedation. (, )
  • Dosage and Administration ()u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 u00a010/2019
  • Warnings and Precautions (, )u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 10/2019
  • 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 , reserve tramadol hydrochloride tablets for use in patients for whom alternative treatment options [e.g., non-opioid analgesics]:
  • Tramadol hydrochloride tablets are an opioid agonist 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 (), 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.
  • No data
  • Use the lowest effective dosage for the shortest duration consistent with individual patient treatment goals. ()
  • 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. ()
  • Monitor patients closely for respiratory depression, especially within the first 24 to 72 hours of initiating therapy and following dosage increases with tramadol hydrochloride tablets and adjust the dosage accordingly. ()
  • The total daily dose may be increased by 50 mg as tolerated every 3 days to reach 200 mg/day (50 mg four times a day). After titration, tramadolu00a0hydrochloride tablets 50 to 100 mg can be administered as needed for pain relief every 4 to 6 hours .(, )
  • Severe Renal Impairment
  • Severe Hepatic Impairment
  • Do not abruptly discontinue tramadol hydrochloride tabletsu00a0in a physically-dependent patientu00a0because rapid discontinuation of opioid analgesics has resulted in serious withdrawal symptoms, uncontrolled pain, and suicide. ()
  • Tramadol Hydrochloride Tablets USP - 50 mg are white, film-coated, unscored, oval-shaped tablets, debossed u201cTVu201d on one side and debossed u201c58u201d on the other side.
  • Tablets: tramadol hydrochloride 50 mg. ()
  • Tramadolu00a0hydrochloride tablets are contraindicated for:
  • Tramadolu00a0hydrochloride tablets are also contraindicated in patients with:
  • Children younger than 12 years of age. ()
  • Postoperative management in children younger than 18 years of age following tonsillectomy and/or adenoidectomy. ()
  • Significant respiratory depression. ()
  • Acute or severe bronchial asthma in an unmonitored setting or in the absence of resuscitative equipment. ()
  • Known or suspected gastrointestinal obstruction, including paralytic ileus. ()
  • Hypersensitivity to tramadol, any other component of this product or opioids. ()
  • Concurrent use of monoamine oxidase inhibitors (MAOIs) or use of MAOIs within the last 14 days. ()
  • No data
  • Serotonin Syndrome
  • Risk of Seizure:
  • Risk of Suicide
  • Adrenal Insufficiency
  • Life-Threatening Respiratory Depression in Patients with Chronicu00a0n- Pulmonary Disease or in Elderly, Cachectic, or Debilitated Patients
  • Severe Hypotension
  • Risks of Use in Patients with Increased Intracranial Pressure, Brainu00a0n- Tumors, Head Injury, or Impaired Consciousness
  • The following serious adverse reactions are described, or described in greater detail, in other sections:
  • The most common incidence of treatment-emergent adverse events (u226515.0%) in patients from clinical trials were dizziness/vertigo, nausea, constipation, headache, somnolence, vomiting and pruritus. ()
  • To report SUSPECTED ADVERSE REACTIONS, contact Teva Pharmaceuticals USA, Inc. at 1-888-838-2872 or FDA at 1-800-FDA-1088 or n
  • Table 2:u00a0 Clinically Significant Drug Interactions with Tramadol Hydrochloride Tablets
  • Mixed Agonist/Antagonist and Partial Agonist Opioid Analgesics
  • 7
  • No data
  • Pregnancy
  • Lactation
  • No data
  • Clinical Presentation
  • Acute overdosage with tramadolu00a0hydrochloride tablets can be manifested by respiratory depression, somnolence progressing to stupor or coma, skeletal muscle flaccidity, cold and clammy skin, constricted pupils, and, in some cases, pulmonary edema, bradycardia, QT prolongation, hypotension, partial or complete airway obstruction, atypical snoring, seizures, and death. Marked mydriasis rather than miosis may be seen with hypoxia in overdose situations.
  • Deaths due to overdose have been reported with abuse and misuse of tramadol . 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.
  • Treatment of Overdose
  • In case of overdose, priorities are the re-establishment of a patent and protected airway and institution of assisted or controlled ventilation, if needed. Employ other supportive measures (including oxygen and vasopressors) in the management of circulatory shock and pulmonary edema as indicated. Cardiac arrest or serious arrhythmias will require advanced life-supporting measures.
  • The opioid antagonists, naloxone or nalmefene, are specific antidotes to respiratory depression resulting from opioid overdose. For clinically significant respiratory or circulatory depression secondary to tramadol overdose, administer an opioid antagonist. Opioid antagonists should not be administered in the absence of clinically significant respiratory or circulatory depression secondary to tramadol overdose.
  • 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 tramadolu00a0hydrochloride 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.
  • Because the duration of opioid reversal is expected to be less than the duration of action of tramadol in tramadol hydrochloride tablets, carefully monitor the patient until spontaneous respiration is reliably reu00adestablished. If the response to an opioid antagonist is suboptimal or only brief in nature, administer additional antagonist as directed by the productu2019s prescribing information.
  • In an individual physically dependent on opioids, administration of the recommended usual dosage of the antagonist will precipitate an acute withdrawal syndrome. The severity of the withdrawal symptoms experienced will depend on the degree of physical dependence and the dose of the antagonist administered. If a decision is made to treat serious respiratory depression in the physically dependent patient, administration of the antagonist should be begun with care and by titration with smaller than usual doses of the antagonist.
  • Tramadol Hydrochloride Tablets USP are an opioid agonist. The chemical name for tramadol hydrochloride, USP is (u00b1)-2-[(dimethylamino)methyl]-1-(3-methoxyphenyl)cyclohexanol hydrochloride. Its structural formula is:
  • CHNOu2022HClu00a0u00a0u00a0u00a0u00a0u00a0u00a0 M.W. 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. The n-octanol/water log partition coefficient (logP) is 1.35 at pH 7. Tramadol Hydrochloride Tablets USP contain 50 mg of tramadol hydrochloride, USP and are white in color. In addition, each tablet contains the following inactive ingredients: colloidal silicon dioxide, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, pregelatinized corn starch, sodium starch glycolate and titanium dioxide.
  • No data
  • Carcinogenesis
  • A slight, but statistically significant, increase in two common murine tumors, pulmonary and hepatic, was observed in an NMRI mouse carcinogenicity study, particularly in aged mice. Mice were dosed orally up to 30 mg/kg in the drinking water (0.36 times the MRHD) for approximately two years, although the study was not done with the Maximum Tolerated Dose. This finding is not believed to suggest risk in humans. No evidence of carcinogenicity was noted in a rat 2-year carcinogenicity study testing oral doses of up to 30 mg/kg in the drinking water, 0.73 times the MRHD.
  • Mutagenesis
  • Tramadol was mutagenic in the presence of metabolic activation in the mouse lymphoma assay. Tramadol was not mutagenic in the bacterial reverse mutation assay using and (Ames), the mouse lymphoma assay in the absence of metabolic activation, the chromosomal aberration assay, or the micronucleus assay in bone marrow.
  • Impairment of Fertility
  • No effects on fertility were observed for tramadol at oral dose levels up to 50 mg/kg in male rats and 75 mg/kg in female rats. These dosages are 1.2 and 1.8 times the maximum recommended human daily dose based on body surface area, respectively.
  • Tramadolu00a0hydrochloride tablets have been given in single oral doses of 50, 75 and 100 mg to patients with pain following surgical procedures and pain following oral surgery (extraction of impacted molars).
  • In single-dose models of pain following oral surgery, pain relief was demonstrated in some patients at doses of 50 mg and 75 mg. A dose of 100 mg tramadolu00a0hydrochloride tablets tended to provide analgesia superior to codeine sulfate 60 mg, but it was not as effective as the combination of aspirin 650 mg with codeine phosphate 60 mg.
  • Tramadolu00a0hydrochloride tablets have been studied in three long-term controlled trials involving a total of 820 patients, with 530 patients receiving tramadol hydrochloride tablets. Patients with a variety of chronic painful conditions were studied in double-blind trials of one to three months duration.u00a0 Average daily doses of approximately 250 mg of tramadolu00a0hydrochloride tablets in divided doses were generally comparable to five doses of acetaminophen 300 mg with codeine phosphate 30 mg (TYLENOL with Codeine #3) daily, five doses of aspirin 325 mg with codeine phosphate 30 mg daily, or two to three doses of acetaminophen 500 mg with oxycodone hydrochloride 5 mg (TYLOX) daily.
  • Titration Trials
  • In a randomized, blinded clinical study with 129 to 132 patients per group, a 10-day titration to a daily tramadol dose of 200 mg (50 mg four times per day), attained in 50 mg increments every 3 days, was found to result in fewer discontinuations due to dizziness or vertigo than titration over only 4 days or no titration.
  • Figure 2:
  • u00a0
  • u00a0
  • Tramadol Hydrochloride Tablets USP, 50 mg, are available as white, film-coated, unscored, oval-shaped tablets, debossed u201cTVu201d on one side and debossed u201c58u201d on the other side. They are available in bottles of 100 (NDC 0093-0058-01) and 500 (NDC 0093-0058-05).
  • Store at 20u00b0 to 25u00b0C (68u00b0 to 77u00b0F) [See USP Controlled Room Temperature].
  • Dispense in a tight, light-resistant container as defined in the USP, with a child-resistant closure (as required).
  • KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN.
  • Advise the patient to read the FDA-approved patient labeling (Medication Guide).
  • Storage and Disposal
  • Because of the risks associated with accidental ingestion, misuse, and abuse, advise patients to store tramadolu00a0hydrochloride tablets securely, out of sight and reach of children, and in a location not accessible by others, including visitors to the home . Inform patients that leaving tramadolu00a0hydrochloride tablets unsecured can pose a deadly risk to others in the home.
  • Advise patients and caregivers that when medicines are no longer needed, they should be disposed of promptly. Inform patients that medicine take-back options are the preferred way to safely dispose of most types of unneeded medicines. If no take back programs or Drug Enforcement Administration (DEA)-registered collectors are available, instruct patients to dispose of tramadolu00a0hydrochloride tablets by following these four steps:
  • u2022 Mix tramadolu00a0hydrochloride tablets (do not crush) with an unpalatable substance such as dirt, cat litter, or used coffee grounds;
  • u2022 Place the mixture in a container such as a sealed plastic bag;
  • u2022 Throw the container in the household trash;
  • u2022 Delete all personal information on the prescription label of the empty bottle.
  • Inform patients that they can visit www.fda.gov/drugdisposal for additional information on disposal of unused medicines.
  • Addiction, Abuse, and Misuse
  • Inform patients that the use of tramadol hydrochloride tablets, even when taken as recommended, can result in addiction, abuse, and misuse, which can lead to overdose and death . Instruct patients not to share tramadolu00a0hydrochloride tablets with others and to take steps to protect tramadolu00a0hydrochloride tablets from theft or misuse.
  • Life-Threatening Respiratory Depression
  • Inform patients of the risk of life-threatening respiratory depression, including information that the risk is greatest when starting tramadolu00a0hydrochloride tablets or when the dosage is increased, and that it can occur even at recommended dosages . Advise patients how to recognize respiratory depression and to seek medical attention if breathing difficulties develop.
  • Accidental Ingestion
  • Inform patients that accidental ingestion, especially by children, may result in respiratory depression or death .
  • Ultra-Rapid Metabolism of Tramadol and Other Risk Factors for Life-Threateningu00a0n- Respiratory Depression in Children
  • Advise caregivers that tramadolu00a0hydrochloride tablets are contraindicated in children younger than 12 years of age and in children younger than 18 years of age following tonsillectomy and/or adenoidectomy. Advise caregivers of children ages 12 to 18 years of age receiving tramadolu00a0hydrochloride tablets to monitor for signs of respiratory depression .
  • Interactions with Benzodiazepines and Other CNS Depressants
  • Inform patients and caregivers that potentially fatal additive effects may occur if tramadolu00a0hydrochloride tablets is used with benzodiazepines, CNS depressants, including alcohol, or some illicit drugs and not to use these concomitantly unless supervised by a healthcare provider .
  • Serotonin Syndrome
  • Inform patients that opioids could cause a rare but potentially life-threatening condition resulting from concomitant administration of serotonergic drugs. Warn patients of the symptoms of serotonin syndrome, and to seek medical attention right away if symptoms develop. Instruct patients to inform their healthcare provider if they are taking, or plan to take serotonergic medications .
  • Seizures
  • Inform patients that tramadolu00a0hydrochloride tablets may cause seizures with concomitant use of serotonergic agents (including SSRIs, SNRIs, and triptans) or drugs that significantly reduce the metabolic clearance of tramadol .
  • MAOI Interaction
  • Inform patients not to take tramadolu00a0hydrochloride tablets while using any drugs that inhibit monoamine oxidase. Patients should not start MAOIs while taking tramadolu00a0hydrochloride tabletsu00a0.
  • Adrenal Insufficiency
  • Inform patients that opioids could cause adrenal insufficiency, a potentially life-threatening condition. Adrenal insufficiency may present with non-specific symptoms and signs such as nausea, vomiting, anorexia, fatigue, weakness, dizziness, and low blood pressure. Advise patients to seek medical attention if they experience a constellation of these symptoms .
  • Important Administration Instructions
  • Important Discontinuation Instructions
  • In order to avoid developing withdrawal symptoms, instruct patients not to discontinue tramadolu00a0hydrochloride tablets without first discussing a tapering plan with the prescriber .
  • Hypotension
  • Inform patients that tramadolu00a0hydrochloride tablets may cause orthostatic hypotension and syncope. Instruct patients how to recognize symptoms of low blood pressure and how to reduce the risk of serious consequences should hypotension occur (e.g., sit or lie down, carefully rise from a sitting or lying position) .
  • Anaphylaxis
  • Inform patients that anaphylaxis has been reported with ingredients contained in tramadol hydrochloride tablets. Advise patients how to recognize such a reaction and when to seek medical attention .
  • Pregnancy
  • Neonatal Opioid Withdrawal Syndrome
  • Inform female patients of reproductive potential that prolonged use of tramadolu00a0hydrochloride tablets during pregnancy can result in neonatal opioid withdrawal syndrome, which may be life-threatening if not recognized and treated and that the patient should inform their healthcare provider if they have used opioids at any time during their pregnancy, especially near the time of birth .
  • Embryo-Fetal Toxicity
  • Inform female patients of reproductive potential that tramadolu00a0hydrochloride tablets may cause fetal harm and to inform the healthcare provider of a known or suspected pregnancy .
  • Lactation
  • Advise women that breastfeeding is not recommended during treatment with tramadolu00a0hydrochloride tabletsu00a0.
  • Infertility
  • Inform patients that chronic use of opioids may cause reduced fertility. It is not known whether these effects on fertility are reversible .
  • Driving or Operating Heavy Machinery
  • Inform patients that tramadolu00a0hydrochloride tablets may impair the ability to perform potentially hazardous activities such as driving a car or operating heavy machinery. Advise patients not to perform such tasks until they know how they will react to the medication .
  • Constipation
  • Advise patients of the potential for severe constipation, including management instructions and when to seek medical attention .
  • Maximum single-dose and 24-hour dose
  • Advise patients not to exceed the single-dose and 24-hour dose limit and the time interval between doses, since exceeding these recommendations can result in respiratory depression, seizures and death .
  • All brand names listed are the registered trademarks of their respective owners and are not trademarks of Teva Pharmaceuticals USA.
  • Manufactured In Czech Republic By:n Opava-Komarov, Czech Republic
  • Manufactured For:n North Wales, PA 19454
  • Rev. AG 12/2019
  • This Medication Guide has been approved by the U.S. Food and Drug Administration.u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 u00a0Rev. B 12/2019
  • NDCn- -0058-
  • traMADOLHydrochlorideTablets USP CIV
  • 50 mg
  • PHARMACIST: Dispense the accompanyingMedication Guide to each patient.
  • Rx only
  • 100 TABLETS
  • TEVA
  • u00a0

Browse Our Services And Processes

Comparator Sourcing for Clinical Trials

Comparator Sourcing for Clinical Trials

GNH India brings over 10 years of experience in Comparator

Read More

Name Patient Supply

Name Patient Supply

Today, the exact cause for many rare diseases remains unknown

Read More

Validated Cold Chain Shipment

Validated Cold Chain Shipment

With shifting of pharma industry from synthetic molecules to biologic

Read More

Clinical Trials Supply

Clinical Trials Supply

STOP SOURCING..... START SMART SOURCING...... COME STRAIGHT TO THE SOURCE

Read More

Pharmaceutical Contract Manufacturing

Pharmaceutical Contract Manufacturing

GNH Provides Contract Manufacturing services for: Generic Medicines with following

Read More

Pricing

Pricing

PRICING POLICY Terms of sales are typically prepaid, unless otherwise

Read More

Disclaimer

Please see the Legal Notice for detailed terms and disclaimers. The Legal Notice governs the use of this Website and by accessing and using this Website you agree to be bound by and accept the Legal Notice.

Browse from other international pharmaceuticals

General

64020 Products

GNH India Brings to over 64036 Product SKUs from India all at 1 place with easy access and global deliveries.

US NDC

71245 Products

GNH India Brings to over 71252 Product SKUs from India all at 1 place with easy access and global deliveries.

Canadian DIN

51046 Products

GNH India Brings to over 51047 Product SKUs from India all at 1 place with easy access and global deliveries.

Swiss Drugs

150 Products

GNH India Brings to over 150 Product SKUs from India all at 1 place with easy access and global deliveries.

NZ Drugs

13296 Products

GNH Brings to over 13298 Product SKUs from India all at 1 place with easy access and global deliveries.

FAQ

Check out our delivery process

Can’t find what
you’re looking for?

Contact US
Pharmexcil
DB
FIEO-2016
SiteLock

Copyright © 2024 GNHIndia .com. All Rights Reserved. Please read Legal Notice for further details.

Disclaimer: Product names, logos, brands and other trademarks featured or referred to are the property of their respective trademark holders.