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Ultram (tramadol) Before taking

dose

Ultram (tramadol) is a narcotic-like pain reliever.

Ultram is used to treat moderate to severe pain. Ultram extended-release is used to treat moderate to severe chronic pain when treatment is needed around the clock.

Ultram may also be used for other purposes not listed in this medication guide.

Important information about Ultram

You should not take Ultram if you are allergic to tramadol, if you have ever been addicted to drugs or alcohol, or if you have ever attempted suicide. Do not take Ultram while you are intoxicated (drunk) or taking any of the following: alcohol or street drugs, narcotic pain medicine, sedatives or tranquilizers, or medicine for depression, anxiety, or mental illness.

Learn the signs of RA and how to relieve the pain.

Seizures (convulsions) have occurred in some people taking this medication. Ultram may be more likely to cause a seizure if you have a history of seizures or head injury, a metabolic disorder, or if you are taking certain medicines such as antidepressants, muscle relaxers, narcotic, or medicine for nausea and vomiting.

Seek emergency medical attention if you think you have used too much of this medicine. An Ultram overdose can be fatal.

Ultram may be habit-forming and should be used only by the person it was prescribed for. Keep the medication in a secure place where others cannot get to it.

Do not crush an Ultram tablet. Ultram is for oral (by mouth) use only. Powder from a crushed tablet should not be inhaled or diluted with liquid and injected into the body. Using this medicine by inhalation or injection can cause life-threatening side effects, overdose, or death.

Before taking Ultram

You should not take Ultram if you are allergic to tramadol, if you have ever been addicted to drugs or alcohol, or if you have ever attempted suicide.

Do not take Ultram while you are intoxicated (drunk) or taking any of the following:

  • alcohol or street drugs;

  • narcotic pain medicine;

  • sedatives or tranquilizers (such as Valium);

    side effects

  • medicine for depression or anxiety; or

  • medicine for mental illness (such as bipolar disorder, schizophrenia).

Seizures have occurred in some people taking Ultram. Talk with your doctor about your seizure risk, which may be higher if you have:

  • a history of drug or alcohol addiction;

  • a history of epilepsy or other seizure disorder;

  • a history of head injury;

  • a metabolic disorder; or

  •  

    if you are also taking an antidepressant, muscle relaxer, narcotic, antipsychotic, or medicine for nausea and vomiting.

To make sure you can safely take Ultram, tell your doctor if you have any of these other conditions:

  • kidney disease (or if you are on dialysis);

  • cirrhosis or other liver disease;

  • a stomach disorder; or

  • a history of depression, mental illness, or thoughts of suicide.

Ultram may be habit forming and should be used only by the person it was prescribed for. Never share Ultram with another person, especially someone with a history of drug abuse or addiction. Keep the medication in a place where others cannot get to it.

Ultram

FDA pregnancy category C. It is not known whether Ultram will harm an unborn baby. Ultram may cause serious or fatal side effects in a newborn if the mother uses this medication during pregnancy or labor. Tell your doctor if you are pregnant or plan to become pregnant while using Ultram. Tramadol can pass into breast milk and may harm a nursing baby. You should not breast-feed while you are taking Ultram. Do not give this medication to anyone younger than 16 years old without the advice of a doctor.

How should I take Ultram?

Take Ultram exactly as prescribed. Never take Ultram in larger amounts, or for longer than recommended by your doctor. Follow the directions on your prescription label. Tell your doctor if the medicine seems to stop working as well in relieving your pain.

medicine

Ultram can be taken with or without food, but take it the same way each time.

Do not crush, chew, or break an Ultram ER tablet. Swallow the tablet whole. Breaking the tablet may cause too much tramadol to be released at one time. This medicine is for oral (by mouth) use only. Powder from a crushed tablet should not be inhaled or diluted with liquid and injected into the body. Using this medicine by inhalation or injection can cause life-threatening side effects, overdose, or death.

If you use the Ultram extended-release tablet, the tablet shell may pass into your stools (bowel movements). This is normal and does not mean that you are not receiving enough of the medicine.

Do not stop using Ultram suddenly, or you could have unpleasant withdrawal symptoms. Talk to your doctor about how to avoid withdrawal symptoms when stopping the medication.

Store Ultram at room temperature away from moisture and heat. Keep track of the amount of medicine used from each new bottle. Ultram is a drug of abuse and you should be aware if anyone is using your medicine improperly or without a prescription.

What happens if I miss a dose?

Take the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose.

 

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222. An Ultram overdose can be fatal.

Overdose symptoms may include extreme drowsiness, shallow breathing, muscle weakness, slow heartbeat, cold or clammy skin, fainting, or seizure.

What should I avoid while taking Ultram?

Do not drink alcohol. It may cause a dangerous decrease in your breathing when used together with tramadol. Ultram may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be alert.

Ultram side effects

Get emergency medical help if you have any of these signs of an allergic reaction to Ultram: hives; difficulty breathing; swelling of your face, lips, tongue, or throat. Stop using Ultram and call your doctor at once if you have any of these serious side effects:

  • agitation, hallucinations, fever, fast heart rate, overactive reflexes, nausea, vomiting, diarrhea, loss of coordination, fainting;

  • seizure (convulsions);

  • taking

    a red, blistering, peeling skin rash; or

  • shallow breathing, weak pulse.

Less serious Ultram side effects may include:

  • dizziness, spinning sensation;

  • constipation, upset stomach;

  • headache;

  • drowsiness; or

  • feeling nervous or anxious.

Kapidex Recommended Dose Dexlansoprazole Dosage

 

KAPIDEX is available as capsules in 30 mg and 60 mg strengths for adult use. Directions for use in each indication are summarized in Table 1.

Table 1: KAPIDEX Dosing Recommendations

Indication Recommended Dose Frequency impairment Child-Pugh

* Controlled studies did not extend beyond 6 months.
Healing of EE 60 mg Once daily for up to 8 weeks
Maintenance of Healed EE 30 mg Once daily*
Symptomatic Non-Erosive GERD 30 mg Once daily for 4 weeks

Special Populations

No adjustment for KAPIDEX is necessary for patients with mild hepatic impairment (Child-Pugh Class A). Consider a maximum daily dose of 30 mg for patients with moderate hepatic impairment (Child-Pugh Class B). No studies have been conducted in patients with severe hepatic impairment (Child-Pugh Class C) [see Use in Specific Populations (8.7) and Clinical Pharmacology (12.5)].

Important Administration Information

KAPIDEX can be taken without regard to food.

KAPIDEX should be swallowed whole.

  • Alternatively, KAPIDEX capsules can be opened and administered as follows: – Open capsule; – Sprinkle intact granules on one tablespoon of applesauce; – Swallow immediately.

Usual Adult Dose for Erosive Esophagitis

Initial dose: 60 mg orally once a day for up to 8 weeks

Maintenance dose: 30 mg orally once a day for up to 6 months

  

Usual Adult Dose for Gastroesophageal Reflux Disease

For treatment of heartburn associated with non-erosive GERD: 30 mg once a day for 4 weeks

  

Renal Dose Adjustments

No adjustment recommended

KAPIDEX

  

Liver Dose Adjustments

Mild hepatic impairment (Child-Pugh A): No adjustment recommended

Moderate hepatic impairment (Child-Pugh B): Maximum daily dose should not exceed 30 mg.

Severe hepatic impairment (Child-Pugh C): No studies have been conducted

  

Precautions

Systemic exposure of dexlansoprazole is generally higher in intermediate and poor metabolizers of the polymorphic liver enzyme CYP450 2C19. In subjects who received a single dose of dexlansoprazole 30 mg or 60 mg, mean dexlansoprazole Cmax and AUC values were up to 2 times higher in intermediate compared to extensive metabolizers; in poor metabolizers, mean Cmax was up to 4 times higher and mean AUC was up to 12 times higher compared to extensive metabolizers.

Safety and effectiveness have not been established in pediatric patients (less than 18 years of age).

  

Dialysis

Data not available

  

Other Comments

Dexlansoprazole may be taken without regard to food; however, some patients may benefit from administering the dose prior to a meal if post-meal symptoms do not resolve under post-fed conditions.

Dexlansoprazole should be swallowed whole; alternatively, the capsules can be opened and sprinkled on one teaspoonful of applesauce and immediately swallowed.

Dexlansoprazole Pregnancy and Breastfeeding

Dexlansoprazole Pregnancy and Breastfeeding dexlansoprazole

Dexlansoprazole Pregnancy

   

Dexlansoprazole has been assigned to pregnancy category B by the FDA. Animal studies at high human doses have revealed no evidence of impaired fertility or fetotoxicity. There are no controlled data in human pregnancy. Dexlansoprazole should only be given during pregnancy when benefit outweighs risk.

Dexlansoprazole Breastfeeding

 

There are no data on the excretion of dexlansoprazole into human milk. Dexlansoprazole and its metabolites are excreted into the milk of rats. The manufacturer suggests that, because of the risk of tumorigenicity in animals, and due to the potential for serious adverse reactions in nursing infants, a decision should be made to discontinue nursing or discontinue the drug, taking into account the importance of the drug to the mother.

dexlansoprazole pregnancy risk

Dexlansoprazole Pregnancy and Breastfeeding dexlansoprazole

Since the full risks of using dexlansoprazole during pregnancy are not known, you should also tell your healthcare provider if you are pregnant.

What should I know before taking dexlansoprazole oral?

If you are:

Pregnant:

Possibly Safe: NO ADEQUATE CONTROLLED HUMAN STUDIES;NO ADVERSE REPRODUCTIVE EFFECTS IN ANIMALS

Dexlansoprazole Pregnancy and Breastfeeding dexlansoprazole

Nursing:

Precaution: CAUTION ADVISED;SIMILAR DRUG LANSOPRAZOLE EXCRETED IN RAT;TUMORIGENIC IN RATS

An adult over 60:

Precaution: FRACTURE RISK W/ HIGH DOSE OR PROLONG. USE >1 YEAR. C.DIFFICILE RISK

Giving dexlansoprazole oral to a child under 12:

Warning: SAFETY AND EFFICACY NOT ESTABLISHED.