Tramadol

Tramadol is an oral medication that is used to help relieve ongoing moderate to moderately severe pain. Tramadol is similar to opioid (narcotic) analgesics. It works in the brain to change how your body feels and responds to pain.

Tramadol is a narcotic-like pain relieving oral medicine that is used as a treatment for moderate to severe pain in adults.

The extended-release-tablet formulation of this drug is used to treat moderate to severe chronic pain when treatment is needed around the clock.

This medication must be prescribed by a doctor and is available by prescription only.

Patients taking this drug should alert their doctors about any problems from the use of this medication and any unusual side effects or symptoms or troublesome side effects.

Care should be taken to ensure this medication is taken exactly as prescribed.

The risk of addiction to most opioid medications is usually, high. However, the risk of addiction to Tramadol is not high.

Read the patient health information leaflet that accompanies the prescription of this medication as well as every time the prescription is refilled. There may be new health care information.

Tramadol is available under the following different brand names: Ultram, Ultram ER, Ryzolt, and ConZip.

Dosages of Tramadol Should Be Given As Follows:

Oral Dose

• Tincture: 5-15 drops or 1-3 drops of fluid extract.

Adult Dosage Forms & Strengths

Tablet: Schedule IV

• 50mg

Suspension, Reconstituted

• 10 mg/mL

Capsule, Extended Release: Schedule IV

• 100 mg (ConZip, Ultram ER)
• 150 mg (ConZip)
• 200 mg (ConZip, Ultram ER)
• 300 mg (ConZip, Ultram ER)

Pediatric Dosing Forms & Strengths:

Tablet: Schedule IV

• Oral dose 50 mg

Suspension, Reconstituted

• 10 mg/mL

Dosage Considerations

Extended-release capsule or oral tablet must not be chewed, crushed, split, or dissolved. Also combined with acetaminophen.

Moderate-to-Severe Pain

Immediate Release

• Chronic: 25 mg oral dose every morning initially; increase by 25-50 mg/day every 3 days up to 50-100 mg orally every 4-6hr as needed; not to exceed 400 mg/day
• Acute: 50-100 mg oral dose every 4-6hr as needed; not to exceed 400 mg/day

Extended-Release Dose

• 100 mg orally once daily initially; increase by 100 mg/day every 5 days; not to exceed 300 mg/day
• Conversion from immediate release to extended release: Round total daily dose down to nearest 100 mg
• Do not chew, crush, split, or dissolve

Dosing Modifications

• Severe renal impairment (CrCl less than 30 mL/min): Immediate release, 50-100 mg orally every 12hr; extended-release not recommended
• Severe hepatic impairment: Immediate release, 50 mg oral tablets every 12hr; extended-release not recommended

Pediatric Dosage Considerations

Immediate Release

• Treatment for patients under 17 years: Safety and efficacy not established
• Treatment for patients 17 years and older (acute): 50-100 mg oral tablets every 4-6hr as needed; not to exceed 400 mg/day
• Treatment for patients 17 years and older (chronic): 25 mg oral tablets every morning initially; increase by 25-50 mg/day every 3 days as separate doses up to 50-100 mg orally every 4-6hr as needed; not to exceed 400 mg/day

Extended-Release Tablets

• Treatment for under 18 years: Safety and efficacy not established. May cause risks to health.

Geriatric Dosage Forms and Strengths:

• Treatment for under 65 years: Initiate at the lower end of dosing range; not to exceed 300 mg/day if over 75 years.
• Treatment for under 75 years: Not to exceed 300 mg of medicine per day; immediate release; use great caution with the extended-release formulation of this medicine

Side effects associated with use of Tramadol, include the following:

• constipation
• nausea
• dizziness
• vertigo
• headache
• drowsiness
• vomiting
• agitation
• anxiety
• mood swings
• euphoria
• hallucinations
• nervousness
• muscle spasms or stiffness
• indigestion
• weakness
• itching
• diarrhea
• dry mouth
• sweating
• feeling unwell (malaise)
• menopausal symptoms
• rash
• urinary frequency
• urinary retention
• dilation of blood vessels (vasodilation)
• visual disturbances
• abnormal gait
• amnesia
• cognitive dysfunction
• depression
• difficulty in concentration
• feeling uneasy
• painful urination
• fatigue
• menstrual dysphoric disorder
• motor system weakness
• lightheadedness upon standing (orthostatic hypotension)
• numbness and tingling
• seizures
• suicidal tendencies
• fainting (syncope)
• fast heart rate
• tremors
• abnormal electrocardiogram (ECG)
• swelling (angioedema)
• cough
• flushing
• high blood pressure (hypertension)
• low blood pressure (hypotension), may be severe
• reduced blood flow to the heart (myocardial ischemia)
• palpitations
• hives
• withdrawal syndrome
• life threatening respiratory depression
• neonatal opioid withdrawal syndrome
• adrenal insufficiency
• abdominal pain
• serotonin syndrome
• severe allergic reaction (anaphylaxis)
• androgen deficiency

If your medical doctor is using this medicine to treat your pain, your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring you for them. Do not start, stop, or change the dosage of any medicine before checking with your doctor, health care provider, or pharmacist first.

Severe Interactions of Tramadol Include:

• Alvimopan
• Procarbazine
• Rasagiline
• Selegiline

Mild interactions of Tramadol Include:

• Asenapine
• Brimonidine
• Darifenacin
• Dextroamphetamine
• Dronedarone
• Eucalyptus
• Lidocaine
• Maraviroc
• Marijuana
• Naloxone
• Nilotinib
• Parecoxib
• Paroxetine
• Ranolazine
• Sage
• Tipranavir
• Ziconotide

Drug Interactions with tramadol are:

• Tramadol has serious interactions with at least 49 different drugs.
• Tramadol has moderate interactions with at least 269 different drugs.

This information does not contain all possible interactions or adverse effects. Therefore, before using this product, tell your doctor or pharmacist of all the products you use. Keep a list of all your medications with you, and share this information with your doctor and pharmacist. Check with your health care professional or doctor for additional medical advice, or if you have health questions, concerns, or for more information about this medicine.

Warnings

This medication contains tramadol. Do not take Ultram, Ultram ER, Ryzolt or ConZip if you are allergic to tramadol or any ingredients contained in this drug.

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center immediately.

Contraindications

Contraindications include hypersensitivity to tramadol or opioids. Known or suspected gastrointestinal obstruction, including paralytic ileus. Concurrent use of monoamine oxidase inhibitors (MAOIs) or use within last 14 days.

Effects of Drug Abuse

Risk of potentiating opioid addiction, abuse, and misuse, which can lead to overdose and death; assess each patient's risk prior to prescribing and monitor all patients regularly for the development of these behaviors or conditions.

Short-Term Effects

• None.

Long-Term Effects

• None.

Pregnancy and Lactation

Pregnancy: Prolonged use of opioid analgesics during pregnancy for medical or nonmedical purposes can result in physical dependence in the neonate and neonatal opioid withdrawal syndrome shortly after birth.

• Medical professionals should observe newborns for symptoms of neonatal opioid withdrawal syndrome and manage accordingly.
• Neonatal seizures, neonatal withdrawal syndrome, fetal death, and stillbirth have been reported with tramadol during post-approval use of tramadol immediate-release products.

Lactation: Monitor infants exposed through breast milk for excess sedation, respiratory depression, or other health problems; withdrawal symptoms can occur in breastfed infants when maternal administration of an opioid analgesic is stopped, or when breastfeeding is stopped.

Talk with your doctor if you have any questions about pregnancy and breastfeeding while taking this medicine.