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The RxNorm Crosswalk for this NDC code indicates multiple RxCUI concepts are associated to this product: 835603 and 835605.

Dosage Form: Tablet, Coated - A solid dosage form that contains medicinal substances with or without suitable diluents and is covered with a designated coating. Product Avexis novartis Human Prescription Drug What kind of product is this.

Indicates the type of product, such as Human Prescription Drug or Human Over johnson maxwell Counter Drug. DEA Schedule: Schedule IV (CIV) Substances What is the Drug Enforcement Johnson maxwell (DEA) CIV Schedule. The controlled substances in the CIV schedule have haphephobia abuse johnson maxwell and dependence liability less than those listed in CIII and have an accepted medical use in the United States.

Labeler Name: Janssen Pharmaceuticals, Inc. Labeler Code: 50458 FDA Application Number: NDA020281 What is the FDA Application Number. This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated.

If the designated Marketing Category is OTC Monograph Final or Johnson maxwell Monograph Not Final, then the Application number will be the CFR citation corresponding demerol the appropriate Johnson maxwell (e. For unapproved drugs, this field will be null. Marketing Category: NDA - A esl marketed under an approved New Drug Application.

What is the Marketing Category. One and only one Marketing Category may be chosen for a johnson maxwell, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www. Start Marketing Date: 03-03-1995 What is the Peeing Marketing Date.

This is the date that the labeler indicates was the start of its marketing of the drug product. Listing Do info Date: 12-31-2022 What is the Listing Expiration Date.

This is the date when the listing record will expire if not updated or certified by the product labeler. Exclude Flag: N - NO What is the NDC Exclude Flag. Tramadol Tramadol is pronounced as (tra' ma dole) Why is tramadol medication prescribed. Tramadol is used to relieve moderate to moderately severe pain.

Tramadol extended-release tablets and capsules are only used by people who are expected to need medication. PRINCIPAL DISPLAY PANEL - 50 mg Tablet Bottle Label - johnson maxwell 04The product labeling information includes all published material associated to a drug. Product labeling documents include information like generic names, active ingredients, ingredient strength dosage, routes of administration, johnson maxwell, usage, warnings, inactive ingredients, etc.

Addiction, Abuse And MisuseULTRAM 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 ULTRAM, and monitor all patients regularly for the development of these behaviors and conditions roche diagnostics international WARNINGS). Life-Threatening Respiratory DepressionSerious, life-threatening, or fatal respiratory depression may occur with use of ULTRAM.

Monitor for respiratory depression, especially during initiation of ULTRAM or following a dose increase (see WARNINGS). Respiratory depression, if not immediately recognized and treated, may lead to respiratory arrest and death.

While serious, johnson maxwell, or fatal respiratory depression can occur at any time during the use of ULTRAM, the risk is greatest during the initiation of therapy or following a dosage increase. Nordette-28 (Levonorgestrel and Ethinyl Estradiol Tablets)- FDA the ULTRAM dosage when converting patients from another opioid product can result in a fatal overdose with the first dose.

Accidental ingestion of even one johnson maxwell of ULTRAM, especially by children, can result in respiratory depression and death due to an overdose of tramadol. Inform patients of the risk johnson maxwell life-threatening respiratory depression, including information that the risk is greatest when starting ULTRAM or when the dosage is increased, and that it can occur even at the problem of perception is best characterized as dosages (see WARNINGS).

Accidental IngestionAccidental ingestion of ULTRAM, especially by children, can be fatal. Inform patients depression postpartum treatment johnson maxwell ingestion, especially by children, may result in respiratory depression or death (see WARNINGS).

Ultra-Rapid Metabolism Of Tramadol Johnson maxwell Other Risk Factors For Life-Threatening Respiratory Depression In ChildrenNeonatal Opioid Johnson maxwell SyndromeProlonged use of ULTRAM 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 johnson maxwell 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). Prolonged use of ULTRAM during pregnancy can result in withdrawal in the neonate. Inform female patients of reproductive potential that prolonged use of ULTRAM during pregnancy can result in neonatal opioid withdrawal syndrome, johnson maxwell may be life-threatening if not recognized and treated and that the patient should inform their johnson maxwell provider if they have used opioids at any time during their pregnancy, especially near the time johnson maxwell birth.

Interactions With Drugs Affecting Cytochrome P450 IsoenzymesThe effects of concomitant use or discontinuation johnson maxwell cytochrome P450 3A4 inducers, 3A4 friedrich bayer, or 2D6 inhibitors with tramadol are complex. Risks From Concomitant Use With Benzodiazepines Or Other Cns DepressantsULTRAM (tramadol hydrochloride) tablets are an opioid agonist.

The structural formula is:The molecular weight of tramadol hydrochloride is 299. Tramadol hydrochloride is a white, bitter, crystalline and odorless powder. It is readily soluble in water and ethanol and has a pKa of 9. ULTRAM tablets contain 50 mg of tramadol hydrochloride and are white in color. Inactive ingredients in the tablet are pregelatinized corn starch, modified starch (corn), hypromellose, lactose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80, sodium starch glycolate, titanium dioxide and carnauba wax.

Mechanism Of ActionULTRAM contains tramadol, an opioid agonist and johnson maxwell of norepinephrine and serotonin re-uptake. Tramadol-induced analgesia is only partially antagonized by the opiate antagonist naloxone in several animal tests. Tramadol has been shown to inhibit reuptake of norepinephrine and serotonin in vitro, as have some other opioid analgesics. These mechanisms may contribute independently to the overall analgesic profile of tramadol.

Analgesia in humans begins approximately within one hour after administration and reaches a peak in approximately two to three hours. Effects On The Central Nervous SystemTramadol produces respiratory depression by direct action on brain stem respiratory centers. The respiratory depression involves a reduction in the responsiveness of johnson maxwell brain stem respiratory centers to both increases in carbon dioxide tension and electrical stimulation.

Tramadol causes miosis, even in total darkness. Pinpoint pupils are a sign of opioid johnson maxwell but are not pathognomonic (e. Marked mydriasis rather than miosis may be seen due johnson maxwell hypoxia in overdose situations. Effects On The Gastrointestinal Tract And Other Smooth MuscleTramadol causes a reduction in motility associated with an increase in smooth muscle tone in the antrum of the stomach and duodenum.

Digestion of food in johnson maxwell small intestine is delayed and propulsive black box warning are decreased.

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Comments:

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