Levo Dromoran

DRUG DESCRIPTION

Levo-Dromoran (levorphanol tartrate) is a potent opioid analgesic with empirical formula C17H23NOC4H6O62H2O and molecular weight 443.5. Each mg of levorphanol tartrate is equivalent to 0.58 mg levorphanol base. Chemically levorphanol is levo-3-hydroxy-N-methylmorphinan. The USP nomenclature is 17-methylmorphinan 3-ol tartrate (1:1)(Salt) dihydrate. The material has 3 asymmetric carbon atoms. The chemical structure is:

 Levo-Dromoran (levorphanol tartrate) Structural Formula Illustration

Levorphanol tartrate is a white crystalline powder, soluble in water and ether but insoluble in chloroform.

Each 1-mL ampul contains 2 mg levorphanol tartrate, 1.8 mg methyl paraben preservative, 0.2 mg propyl paraben preservative, sodium hydroxide to adjust pH to approximately 4.3 and Water for Injection.

Each milliliter in the 10 mL vials contains 2 mg levorphanol tartrate, 4.5 mg phenol preservative, sodium hydroxide to adjust pH to approximately 4.3 and Water for Injection.

Each tablet contains 2 mg levorphanol tartrate, lactose, corn starch, stearic acid and talc.

What are the possible side effects of levorphanol (Levo-Dromoran)?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have any of these serious side effects:

  • shallow breathing, slow heartbeat;
  • seizure (convulsions);
  • cold, clammy skin;
  • confusion;
  • severe weakness or dizziness; or
  • feeling light-headed, fainting.

Less serious side effects are more likely to occur, such...

Read All Potential Side Effects and See Pictures of Levo Dromoran

What are the precautions when taking levorphanol (Levo Dromoran)?

Before taking levorphanol, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

This medication should not be used if you have certain medical conditions. Before using this medicine, consult your doctor or pharmacist if you have: severe breathing problems (e.g., respiratory depression, severe or acute asthma), certain bowel diseases (e.g., paralytic ileus, toxic megacolon), intoxication with medications that slow the nervous system or your breathing (CNS/respiratory depressants such as alcohol or tranquilizers/sedatives).

Before using this medication, tell your doctor or pharmacist your...

Read All Potential Precautions of Levo Dromoran


Levo Dromoran Consumer (continued)

SIDE EFFECTS: Nausea, vomiting, constipation, lightheadedness, dizziness, drowsiness, dry mouth, flushing, or vision problems may occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.

To prevent constipation, maintain a diet adequate in fiber, drink plenty of water, and exercise. If you become constipated while using this drug, consult your pharmacist for help in selecting a laxative (e.g., stimulant-type with stool softener).

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor immediately if any of these unlikely but serious side effects occur: slow/shallow breathing, mental/mood changes (e.g., confusion, depression, abnormal thoughts), fainting, trouble urinating.

Tell your doctor immediately if any of these rare but very serious side effects occur: severe stomach/abdominal pain, change in the amount of urine, seizures, fast/slow/irregular heartbeat.

A very serious allergic reaction to this drug is rare. However, seek immediate medical attention if you notice any of the following symptoms of a serious allergic reaction: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

PRECAUTIONS: Before taking levorphanol, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

This medication should not be used if you have certain medical conditions. Before using this medicine, consult your doctor or pharmacist if you have: severe breathing problems (e.g., respiratory depression, severe or acute asthma), certain bowel diseases (e.g., paralytic ileus, toxic megacolon), intoxication with medications that slow the nervous system or your breathing (CNS/respiratory depressants such as alcohol or tranquilizers/sedatives).

Before using this medication, tell your doctor or pharmacist your medical history, especially of: brain disorders (e.g., seizures, head injury, tumor, increased intracranial pressure), heart problems (e.g., irregular heartbeat), low blood pressure, lung diseases (e.g., chronic obstructive pulmonary disease-COPD, emphysema, low oxygen/high carbon dioxide in the blood), disease of the pancreas (e.g., pancreatitis), mental/mood disorders (e.g., toxic psychosis), a certain spinal problem (kyphoscoliosis), gallbladder disease, personal or family history of regular use/abuse of drugs/alcohol, kidney disease, liver disease, adrenal gland problem (e.g., Addison's disease), difficulty urinating (e.g., due to enlarged prostate or urethral stricture), underactive thyroid (hypothyroidism).

Before having surgery, tell your doctor or dentist that you are taking this medication.

This drug may make you dizzy or drowsy. Do not drive, use machinery, or do any activity that requires alertness until you are sure you can perform such activities safely. Avoid alcoholic beverages.

To lower your risk of dizziness and lightheadedness, get up slowly when rising from a sitting or lying position.

Caution is advised when using this drug in the elderly because they may be more sensitive to its effects, especially slow/shallow breathing and drowsiness.

During pregnancy, this medication should be used only when clearly needed. Using it for long periods or in high doses near the expected delivery date is not recommended because of possible harm to the unborn baby. Discuss the risks and benefits with your doctor. Infants born to mothers who have used this medication for an extended time may have withdrawal symptoms such as irritability, abnormal/persistent crying, vomiting, or diarrhea. Tell your doctor immediately if you notice any of these symptoms in your newborn.

Based on information from related drugs, this medication may pass into breast milk. Consult your doctor before breast-feeding.


Levo Dromoran Patient Information Including Side Effects

Brand Names: Levo-Dromoran

Generic Name: levorphanol (Pronunciation: lee VOR fa nole)

  • What is levorphanol (Levo Dromoran)?
  • What are the possible side effects of levorphanol (Levo Dromoran)?
  • What is the most important information I should know about levorphanol (Levo Dromoran)?
  • What should I discuss with my healthcare provider before taking levorphanol (Levo Dromoran)?
  • How should I take levorphanol (Levo Dromoran)?
  • What happens if I miss a dose (Levo Dromoran)?
  • What happens if I overdose (Levo Dromoran)?
  • What should I avoid while taking levorphanol (Levo Dromoran)?
  • What other drugs will affect levorphanol (Levo Dromoran)?
  • Where can I get more information?

What is levorphanol (Levo Dromoran)?

Levorphanol is in a group of drugs called narcotic pain relievers. It is similar to morphine.

Levorphanol is used to treat moderate to severe pain.

Levorphanol may also be used for purposes other than those listed in this medication guide.

What are the possible side effects of levorphanol (Levo Dromoran)?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have any of these serious side effects:

  • shallow breathing, slow heartbeat;
  • seizure (convulsions);
  • cold, clammy skin;
  • confusion;
  • severe weakness or dizziness; or
  • feeling light-headed, fainting.

Less serious side effects are more likely to occur, such as:

  • nausea, vomiting, constipation, loss of appetite;
  • dizziness, headache, tired feeling;
  • dry mouth;
  • sweating;
  • itching;
  • urinating less than usual; or
  • loss of interest in sex.

This is not a complete list of side effects and others may occur. Tell your doctor about any unusual or bothersome side effect. You may report side effects to FDA at 1-800-FDA-1088.

What is the most important information I should know about levorphanol (Levo Dromoran)?

Levorphanol may be habit-forming and should be used only by the person it was prescribed for. Levorphanol should never be given to another person, especially someone who has a history of drug abuse or addiction. Keep the medication in a secure place where others cannot get to it.

Do not drink alcohol while you are taking levorphanol. Dangerous side effects or death can occur when alcohol is combined with a narcotic pain medicine. Check your food and medicine labels to be sure these products do not contain alcohol.

Never take more levorphanol than is prescribed. Tell your doctor if the medicine seems to stop working as well in relieving your pain.

Levorphanol can cause side effects that may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be awake and alert.

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

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