Papaverine 30mg/ml Inj, 2ml
It is used to treat muscle problems that lead to spasms.It is used to treat muscle spasms of the GI (gastrointestinal) tract, gallbladder system, or urinary system.It may be given to you for other reasons. Talk with the doctor.
Drug Class
Antispasmodic; Vasodilator
Pharmacologic Class
Opium alkaloid; Phosphodiesterase inhibitor (non-selective)
Pregnancy Category
Category C
FDA Approved
Jan 1970
DEA Schedule
Not Controlled
Overview
What is this medicine?
Papaverine is a medication that helps relax muscles, especially in blood vessels. It's used to improve blood flow or relieve spasms in different parts of the body, like the gut or blood vessels.
How to Use This Medicine
To use this medication correctly, follow your doctor's instructions and carefully read all accompanying information. Take this medication exactly as directed, and be sure to follow all instructions provided. This medication is administered via injection, either into a muscle or a vein.
If you need to store this medication at home, consult with your doctor, nurse, or pharmacist to determine the proper storage procedure.
If you miss a dose, contact your doctor immediately to receive guidance on the appropriate course of action.
If you need to store this medication at home, consult with your doctor, nurse, or pharmacist to determine the proper storage procedure.
If you miss a dose, contact your doctor immediately to receive guidance on the appropriate course of action.
Lifestyle & Tips
- Avoid sudden changes in position (e.g., standing up quickly) to prevent dizziness or fainting due to blood pressure drop.
- Avoid alcohol, as it can increase side effects like dizziness and drowsiness.
- Report any unusual symptoms or side effects to your healthcare provider.
Available Forms & Alternatives
Available Strengths:
Dosing & Administration
Adult Dosing
Standard Dose:
For spasm: 30-120 mg IV or IM, repeated every 3 hours as needed. For cerebral/peripheral ischemia: 30-120 mg IV or IM, 3-5 times daily. For intracavernosal use (ED): 7.5-60 mg, titrated to effect.
Dose Range:
30 - 120 mg
Condition-Specific Dosing:
acutevascularspasm:
30-120 mg IV or IM, repeated every 3 hours as needed.
cerebralperipheralischemia:
30-120 mg IV or IM, 3-5 times daily.
erectiledysfunction_intracavernosal:
Initial: 7.5 mg, titrate up to 60 mg based on response and tolerability. Max: 60 mg per injection, not more than 3 times per week, with at least 24 hours between doses.
Pediatric Dosing
Neonatal:
Not established
Infant:
Not established
Child:
Not established (limited data, generally not recommended)
Adolescent:
Not established
Dose Adjustments
Renal Impairment:
Mild:
No specific adjustment recommended.
Moderate:
Use with caution; consider lower doses or extended intervals due to potential accumulation of metabolites.
Severe:
Use with caution; consider lower doses or extended intervals due to potential accumulation of metabolites.
Dialysis:
Considerations: Not well studied; metabolites may accumulate. Monitor for adverse effects.
Hepatic Impairment:
Mild:
No specific adjustment recommended.
Moderate:
Use with caution; consider lower doses due to extensive hepatic metabolism.
Severe:
Use with caution; consider lower doses due to extensive hepatic metabolism. Monitor liver function.
Pharmacology
Mechanism of Action
Papaverine is a non-narcotic opium alkaloid that directly relaxes smooth muscle, particularly in the large blood vessels, bronchi, and gastrointestinal tract. Its mechanism involves the inhibition of phosphodiesterase enzymes, leading to increased intracellular concentrations of cyclic adenosine monophosphate (cAMP) and cyclic guanosine monophosphate (cGMP). This increase in cyclic nucleotides results in reduced intracellular calcium levels, leading to smooth muscle relaxation and vasodilation.
Pharmacokinetics
Absorption:
Bioavailability:
Variable (oral); Rapid and complete (IM/IV)
Tmax:
IM: ~30 minutes; IV: Immediate
FoodEffect:
Not applicable for injectable form.
Distribution:
Vd:
Not precisely quantified, but widely distributed.
ProteinBinding:
Approximately 90%
CnssPenetration:
Limited (does not readily cross the blood-brain barrier in significant amounts to exert CNS effects at therapeutic doses)
Elimination:
HalfLife:
0.5-2 hours (variable, depends on route and individual)
Clearance:
High hepatic clearance
ExcretionRoute:
Primarily renal (as metabolites)
Unchanged:
<1% (renal)
Pharmacodynamics
OnsetOfAction:
IV: Immediate; IM: Within minutes
PeakEffect:
IV: Within minutes; IM: 30-60 minutes
DurationOfAction:
1-2 hours (IV/IM)
Safety & Warnings
Side Effects
Serious Side Effects: Seek Medical Help Immediately
Although rare, some people may experience severe and potentially life-threatening side effects while taking this medication. If you notice any of the following symptoms, contact your doctor or seek medical attention right away:
Signs of an allergic reaction, such as:
+ Rash
+ Hives
+ Itching
+ Red, swollen, blistered, or peeling skin with or without fever
+ Wheezing
+ Tightness in the chest or throat
+ Trouble breathing, swallowing, or talking
+ Unusual hoarseness
+ Swelling of the mouth, face, lips, tongue, or throat
Signs of liver problems, including:
+ Dark urine
+ Tiredness
+ Decreased appetite
+ Upset stomach or stomach pain
+ Light-colored stools
+ Vomiting
+ Yellow skin or eyes
Signs of high blood pressure, such as:
+ Severe headache or dizziness
+ Passing out
+ Changes in eyesight
Fast or abnormal heartbeat
Other Possible Side Effects
Like all medications, this drug can cause side effects. While many people may not experience any side effects or only have mild ones, it's essential to discuss any concerns with your doctor. If you experience any of the following side effects or any other unusual symptoms, contact your doctor for advice:
Headache
Constipation
Diarrhea
Stomach pain
Upset stomach
Vomiting
Decreased appetite
Dizziness
Drowsiness
Fatigue
Weakness
Excessive sweating
* Flushing
Reporting Side Effects
This list is not exhaustive, and you may experience other side effects. If you have questions or concerns about side effects, contact your doctor. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch.
Although rare, some people may experience severe and potentially life-threatening side effects while taking this medication. If you notice any of the following symptoms, contact your doctor or seek medical attention right away:
Signs of an allergic reaction, such as:
+ Rash
+ Hives
+ Itching
+ Red, swollen, blistered, or peeling skin with or without fever
+ Wheezing
+ Tightness in the chest or throat
+ Trouble breathing, swallowing, or talking
+ Unusual hoarseness
+ Swelling of the mouth, face, lips, tongue, or throat
Signs of liver problems, including:
+ Dark urine
+ Tiredness
+ Decreased appetite
+ Upset stomach or stomach pain
+ Light-colored stools
+ Vomiting
+ Yellow skin or eyes
Signs of high blood pressure, such as:
+ Severe headache or dizziness
+ Passing out
+ Changes in eyesight
Fast or abnormal heartbeat
Other Possible Side Effects
Like all medications, this drug can cause side effects. While many people may not experience any side effects or only have mild ones, it's essential to discuss any concerns with your doctor. If you experience any of the following side effects or any other unusual symptoms, contact your doctor for advice:
Headache
Constipation
Diarrhea
Stomach pain
Upset stomach
Vomiting
Decreased appetite
Dizziness
Drowsiness
Fatigue
Weakness
Excessive sweating
* Flushing
Reporting Side Effects
This list is not exhaustive, and you may experience other side effects. If you have questions or concerns about side effects, contact your doctor. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch.
Seek Immediate Medical Attention If You Experience:
- Severe dizziness or fainting
- Rapid or irregular heartbeat
- Yellowing of skin or eyes (jaundice)
- Dark urine or pale stools
- Unusual fatigue or weakness
- Severe headache
- Vision changes
- Rash or itching
Before Using This Medicine
Before Taking This Medication: Important Information to Share with Your Doctor
It is essential to inform your doctor about the following:
Any allergies you have, including allergies to this medication, its components, or other substances, such as foods or drugs. Be sure to describe the symptoms you experienced.
If you have a heart block, a condition where the electrical signals between your heart's chambers are delayed or blocked.
This list is not exhaustive, and it is crucial to discuss all your medications (prescription, over-the-counter, natural products, and vitamins) and health issues with your doctor and pharmacist. They will help determine if it is safe to take this medication in conjunction with your other treatments and health conditions.
Remember, do not start, stop, or adjust the dosage of any medication without first consulting your doctor to ensure your safety.
It is essential to inform your doctor about the following:
Any allergies you have, including allergies to this medication, its components, or other substances, such as foods or drugs. Be sure to describe the symptoms you experienced.
If you have a heart block, a condition where the electrical signals between your heart's chambers are delayed or blocked.
This list is not exhaustive, and it is crucial to discuss all your medications (prescription, over-the-counter, natural products, and vitamins) and health issues with your doctor and pharmacist. They will help determine if it is safe to take this medication in conjunction with your other treatments and health conditions.
Remember, do not start, stop, or adjust the dosage of any medication without first consulting your doctor to ensure your safety.
Precautions & Cautions
It is essential to inform all your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are taking this medication. If you are pregnant, planning to become pregnant, or are breast-feeding, be sure to discuss this with your doctor. You and your doctor will need to carefully weigh the benefits and risks of this medication to both you and your baby.
Overdose Information
Overdose Symptoms:
- Nausea
- Vomiting
- Diarrhea
- Weakness
- Drowsiness
- Lethargy
- Ataxia
- Nystagmus
- Diplopia
- Flushing
- Tachycardia
- Hypotension
- Hyperventilation
- Acidosis
- Coma
What to Do:
Call 1-800-222-1222 (Poison Control). Seek immediate medical attention. Treatment is supportive, including gastric lavage, activated charcoal, and measures to support blood pressure and respiration.
Drug Interactions
Major Interactions
- Levodopa (may reduce efficacy of levodopa)
- Antihypertensives (additive hypotensive effects)
Moderate Interactions
- CNS depressants (additive CNS depression)
- Alcohol (additive CNS depression, increased hypotensive risk)
Monitoring
Baseline Monitoring
Blood Pressure (BP)
Rationale: To establish baseline and monitor for hypotension, especially with IV administration.
Timing: Prior to administration
Heart Rate (HR)
Rationale: To establish baseline and monitor for tachycardia or arrhythmias.
Timing: Prior to administration
Liver Function Tests (LFTs)
Rationale: Papaverine is extensively metabolized by the liver; baseline LFTs are important, especially in patients with pre-existing hepatic impairment or prolonged use.
Timing: Prior to initiation, if clinically indicated
Routine Monitoring
Blood Pressure (BP)
Frequency: Frequently during IV administration (e.g., every 5-15 minutes initially), then as clinically indicated.
Target: Maintain within patient's normal range, avoiding symptomatic hypotension.
Action Threshold: Significant drop (e.g., >20 mmHg systolic) or symptomatic hypotension; reduce rate or discontinue.
Heart Rate (HR)
Frequency: Frequently during IV administration, then as clinically indicated.
Target: Maintain within patient's normal range.
Action Threshold: Significant tachycardia or bradycardia; assess and intervene.
Injection Site
Frequency: Regularly during and after administration.
Target: Absence of pain, swelling, redness, or signs of phlebitis.
Action Threshold: Signs of irritation, pain, or extravasation; discontinue infusion and manage site.
Liver Function Tests (LFTs)
Frequency: Periodically, especially with prolonged use or in patients with hepatic impairment.
Target: Within normal limits.
Action Threshold: Significant elevation of transaminases (e.g., >3x ULN); consider discontinuation.
Symptom Monitoring
- Dizziness
- Lightheadedness
- Nausea
- Abdominal discomfort
- Headache
- Flushing
- Sweating
- Visual disturbances
- Signs of allergic reaction (rash, itching, swelling)
- Signs of liver dysfunction (jaundice, dark urine, fatigue)
Special Patient Groups
Pregnancy
Category C. Use only if the potential benefit justifies the potential risk to the fetus. Animal studies have shown adverse effects, but there are no adequate and well-controlled studies in pregnant women.
Trimester-Specific Risks:
First Trimester:
Potential for fetal harm; avoid if possible.
Second Trimester:
Use with caution; monitor for maternal and fetal effects.
Third Trimester:
Use with caution; monitor for maternal and fetal effects.
Lactation
L3 (Moderately Safe). It is not known whether papaverine is excreted in human milk. Use with caution; consider potential infant exposure and risk vs. maternal benefit. Monitor breastfed infant for adverse effects.
Infant Risk:
Low to moderate; potential for drowsiness or GI upset in infant, though unlikely with typical doses.
Pediatric Use
Safety and efficacy not established in pediatric patients. Generally not recommended for use in children.
Geriatric Use
Use with caution in elderly patients, as they may be more susceptible to hypotensive effects and other adverse reactions. Start with lower doses and titrate slowly. Monitor closely for dizziness, falls, and changes in mental status.
Clinical Information
Clinical Pearls
- Papaverine injection should be administered slowly, especially IV, to minimize the risk of adverse effects such as cardiac arrhythmias and profound hypotension.
- Due to its short half-life, frequent dosing may be required for sustained effect.
- While historically used for various spasmodic conditions, its use has declined with the availability of more specific and safer agents. Its primary current use is often in compounding for intracavernosal injections for erectile dysfunction.
- Monitor liver function tests periodically, especially with prolonged use, as hepatic hypersensitivity with jaundice has been reported.
Alternative Therapies
- Nitrates (e.g., nitroglycerin, isosorbide) for vasodilation
- Calcium channel blockers (e.g., nifedipine, diltiazem) for vasodilation and smooth muscle relaxation
- Alpha-blockers (e.g., prazosin, tamsulosin) for vasodilation
- PDE5 inhibitors (e.g., sildenafil, tadalafil) for erectile dysfunction
- Anticholinergics (e.g., dicyclomine, hyoscyamine) for GI/urinary spasms
Cost & Coverage
Average Cost:
Varies widely, typically low cost for generic injectable. per 2ml vial
Generic Available:
Yes
Insurance Coverage:
Tier 1 or 2 (Generic)
General Drug Facts
If your symptoms or health problems do not improve or worsen over time, it is essential to contact your doctor for further evaluation and guidance.
To ensure safe and effective use of your medication, never share your prescription with others, and do not take medication that has been prescribed to someone else.
Store all medications in a secure location, out of the reach of children and pets, to prevent accidental ingestion or exposure.
Proper disposal of unused or expired medications is crucial. Do not flush medications down the toilet or pour them down the drain unless specifically instructed to do so by your pharmacist or healthcare provider. If you are unsure about the best method for disposing of your medication, consult with your pharmacist, who can provide guidance on safe disposal practices or inform you about potential drug take-back programs in your area.
Some medications may come with an additional patient information leaflet, so it is a good idea to check with your pharmacist to see if this is the case. If you have any questions or concerns about your medication, do not hesitate to reach out to your doctor, nurse, pharmacist, or other healthcare provider for assistance.
In the event of a suspected overdose, it is critical to seek immediate medical attention or contact your local poison control center. Be prepared to provide information about the medication taken, including the dosage, time of ingestion, and any other relevant details to ensure prompt and effective treatment.
To ensure safe and effective use of your medication, never share your prescription with others, and do not take medication that has been prescribed to someone else.
Store all medications in a secure location, out of the reach of children and pets, to prevent accidental ingestion or exposure.
Proper disposal of unused or expired medications is crucial. Do not flush medications down the toilet or pour them down the drain unless specifically instructed to do so by your pharmacist or healthcare provider. If you are unsure about the best method for disposing of your medication, consult with your pharmacist, who can provide guidance on safe disposal practices or inform you about potential drug take-back programs in your area.
Some medications may come with an additional patient information leaflet, so it is a good idea to check with your pharmacist to see if this is the case. If you have any questions or concerns about your medication, do not hesitate to reach out to your doctor, nurse, pharmacist, or other healthcare provider for assistance.
In the event of a suspected overdose, it is critical to seek immediate medical attention or contact your local poison control center. Be prepared to provide information about the medication taken, including the dosage, time of ingestion, and any other relevant details to ensure prompt and effective treatment.