Sumatriptan 6mg/0.5ml Pf Inj2x0.5ml

Manufacturer DR.REDDY'S LABORATORIES, INC. Active Ingredient Sumatriptan Injection(soo ma TRIP tan) Pronunciation soo ma TRIP tan
It is used to treat migraine headaches. It is used to treat cluster headaches.
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Drug Class
Antimigraine agent
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Pharmacologic Class
Selective serotonin 5-HT1B/1D receptor agonist
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Pregnancy Category
C
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FDA Approved
Dec 1992
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DEA Schedule
Not Controlled

Overview

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What is this medicine?

Sumatriptan injection is a medication used to treat acute migraine headaches and cluster headaches. It works by narrowing blood vessels in the brain and affecting certain nerves, which helps to relieve headache pain and other symptoms like nausea and sensitivity to light and sound. It is not for preventing headaches, but for treating them once they start.
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How to Use This Medicine

Taking Your Medication Correctly

To use this medication safely and effectively, follow your doctor's instructions carefully. Read all the information provided with your medication and follow the instructions closely. If your headache does not improve after the first dose, consult your doctor. If your headache improves but then returns, or if you only experience partial relief, you may take a second dose if your doctor has advised you to do so. Be sure to wait the recommended number of hours before taking another dose, even if you used a different form of this medication for the first dose.

Administering the Injection

The injection should be given under the skin as soon as possible after the onset of the attack. Before using this medication, make sure you understand how to administer it correctly. Read the package insert and instructions for use that come with your medication. If you have any questions or concerns, consult your doctor or pharmacist. It's also essential to know the correct injection site. If you're unsure, consult your doctor before proceeding.

Precautions and Safety Measures

Before and after using your medication, wash your hands thoroughly. Do not use the medication if the solution appears cloudy, is leaking, or contains particles. Additionally, do not use the medication if the solution has changed color. After use, dispose of the needle in a designated needle/sharp disposal box. Do not reuse needles or other items. When the disposal box is full, follow local regulations for proper disposal. If you have any questions or concerns, consult your doctor or pharmacist.

Storage and Disposal

Store your medication at room temperature, avoiding refrigeration or freezing.

Missed Doses

Since this medication is taken as needed, do not take it more frequently than advised by your doctor.
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Lifestyle & Tips

  • Administer the injection as soon as headache symptoms begin, but do not use it to prevent headaches.
  • Do not use more than two 6 mg injections in a 24-hour period, and ensure at least 1 hour between doses.
  • Avoid driving or operating machinery until you know how sumatriptan affects you, as it can cause dizziness or drowsiness.
  • Inform your doctor about all other medications you are taking, especially antidepressants (SSRIs/SNRIs), other migraine medications (triptans, ergotamines), and MAOIs.
  • Report any chest pain, shortness of breath, or severe side effects immediately.

Dosing & Administration

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Adult Dosing

Standard Dose: 6 mg subcutaneous injection, may repeat once after 1 hour if needed
Dose Range: 6 - 12 mg

Condition-Specific Dosing:

migraine: 6 mg subcutaneous injection at the onset of migraine symptoms. A second 6 mg dose may be administered 1 hour after the first dose if symptoms persist or recur. Maximum dose is 12 mg in 24 hours.
cluster_headache: 6 mg subcutaneous injection at the onset of cluster headache symptoms. Maximum dose is 12 mg in 24 hours (two 6 mg injections separated by at least 1 hour).
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Pediatric Dosing

Neonatal: Not established
Infant: Not established
Child: Not established
Adolescent: Not established (Safety and efficacy not established in patients under 18 years of age for migraine or cluster headache.)
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Dose Adjustments

Renal Impairment:

Mild: No dose adjustment typically needed.
Moderate: No dose adjustment typically needed.
Severe: No dose adjustment typically needed.
Dialysis: No specific recommendations; sumatriptan is not significantly cleared by dialysis.

Hepatic Impairment:

Mild: No dose adjustment typically needed.
Moderate: Consider lower initial dose (e.g., 3 mg) and monitor for adverse effects. Maximum single dose should not exceed 6 mg.
Severe: Contraindicated due to impaired metabolism and increased exposure.

Pharmacology

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Mechanism of Action

Sumatriptan is a selective agonist for 5-hydroxytryptamine1 (5-HT1B/1D) receptors. It is believed to exert its antimigraine effects by causing vasoconstriction of intracranial blood vessels, particularly those of the carotid arterial circulation, which are dilated during a migraine attack. It also inhibits the release of pro-inflammatory neuropeptides (e.g., substance P, calcitonin gene-related peptide) from trigeminal nerve endings.
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Pharmacokinetics

Absorption:

Bioavailability: 97% (subcutaneous)
Tmax: 12 minutes (subcutaneous)
FoodEffect: Not applicable for injection.

Distribution:

Vd: 2.7 L/kg
ProteinBinding: 14-21%
CnssPenetration: Limited

Elimination:

HalfLife: Approximately 2 hours
Clearance: 1160 mL/min (total plasma clearance)
ExcretionRoute: Renal (approximately 60% as inactive metabolite, 3% as unchanged drug), Fecal (approximately 40% as inactive metabolite)
Unchanged: Approximately 22% (oral), 3% (subcutaneous)
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Pharmacodynamics

OnsetOfAction: Approximately 10-15 minutes (subcutaneous)
PeakEffect: Approximately 1 hour (subcutaneous)
DurationOfAction: Up to 24 hours (though headache recurrence is common)

Safety & Warnings

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Side Effects

Urgent Side Effects: Seek Medical Help Right Away

Although rare, this medication can cause severe and potentially life-threatening side effects. If you experience any of the following symptoms, contact your doctor or seek medical attention immediately:

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
Note: In rare cases, allergic reactions can be fatal.
Signs of high blood pressure, including:
+ Severe headache
+ Dizziness
+ Fainting
+ Changes in eyesight
Seizures
Loss of eyesight (which can be long-lasting)
Abnormal sensations, such as:
+ Burning
+ Numbness
+ Tingling
Discoloration of the skin, lips, nail beds, fingers, or toes (blue or gray)
Gastrointestinal problems, including:
+ Diarrhea
+ Constipation
+ Severe stomach pain
+ Bloody diarrhea
Other symptoms, such as:
+ Belly pain after meals
+ Fever
+ Weight loss
+ Cramps and pain in legs or hips
+ Feeling of heaviness or tightness in the leg muscles
+ Feeling cold
+ Burning or aching pain in the feet or toes

Serotonin Syndrome: A Potentially Life-Threatening Condition

There is a risk of developing serotonin syndrome, a severe and potentially deadly condition, especially when taking certain other medications. If you experience any of the following symptoms, contact your doctor immediately:

Agitation
Changes in balance
Confusion
Hallucinations
Fever
Fast or abnormal heartbeat
Flushing
Muscle twitching or stiffness
Seizures
Shivering or shaking
Excessive sweating
Severe diarrhea
Upset stomach
Vomiting
Severe headache

Brain Blood Vessel Problems: A Rare but Serious Condition

In rare cases, this medication can cause brain blood vessel problems, including stroke. If you experience any of the following symptoms, contact your doctor immediately:

Weakness on one side of the body
Trouble speaking or thinking
Changes in balance
Drooping on one side of the face
Changes in eyesight

Other Side Effects

Like all medications, this drug can cause side effects. While many people may not experience any side effects or only minor ones, it's essential to contact your doctor if you're bothered by any of the following:

Dizziness
Drowsiness
Fatigue
Weakness
Flushing
Feeling of warmth
Upset stomach
Vomiting
Irritation at the injection site

Reporting 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.
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Seek Immediate Medical Attention If You Experience:

  • Chest pain, tightness, or pressure (can spread to jaw or arm)
  • Shortness of breath
  • Sudden severe stomach pain and bloody diarrhea (rare, but serious)
  • Numbness, tingling, or weakness in any part of the body
  • Vision changes
  • Slurred speech
  • Signs of serotonin syndrome: agitation, confusion, hallucinations, rapid heart rate, sweating, muscle stiffness or twitching, loss of coordination, severe nausea, vomiting, or diarrhea.
  • Allergic reactions: rash, hives, swelling of face/lips/tongue/throat, difficulty breathing.
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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. Describe the allergic reaction and its symptoms.
Certain health conditions, including:
+ High blood pressure
+ Liver disease
A history of specific health problems, such as:
+ Chest pain or pressure
+ Diseased arteries in the legs or arms
+ Heart attack
+ Heart disease
+ Poor blood flow in the heart, brain, bowel, or kidney
+ Stroke or transient ischemic attack (TIA)
+ Certain types of migraines, including hemiplegic or basilar migraines
+ Abnormal heart rhythms, such as Wolff-Parkinson-White syndrome
Recent use of certain antidepressant medications, including isocarboxazid, phenelzine, or tranylcypromine, within the last 14 days. Taking this medication within 14 days of these drugs can cause severe high blood pressure.
Concurrent use of another medication that contains the same active ingredient.
Use of other medications for migraine or headache, such as:
+ Almotriptan, eletriptan, frovatriptan, naratriptan, rizatriptan, or zolmitriptan, within the last 24 hours
+ Ergotamine, methysergide, dihydroergotamine, or similar medications, within the last 24 hours

This list is not exhaustive, and it is crucial to discuss all your medications, including prescription and over-the-counter drugs, natural products, and vitamins, with your doctor and pharmacist. Ensure that it is safe to take this medication with your existing medications and health conditions. Do not start, stop, or change the dose of any medication without consulting your doctor.
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Precautions & Cautions

Important Warnings and Cautions for Patients Taking This Medication

If you are taking this medication, it is essential to inform all your healthcare providers, including doctors, nurses, pharmacists, and dentists, about your treatment.

Precautions and Safety Measures

Avoid driving and engaging in activities that require alertness until you understand how this medication affects you.
Monitor your blood pressure regularly, as prescribed by your doctor, since this medication can cause high blood pressure.
Note that this medication is not intended to prevent or reduce the frequency of migraine headaches. If you experience a headache that is different from your typical migraine, consult your doctor before taking this medication.
Be cautious not to exceed the recommended dose or frequency, as this may worsen your headaches. If you have risk factors for heart disease, such as high blood pressure, high cholesterol, being overweight, having high blood sugar or diabetes, smoking, being a male over 40 years old, or having a family history of early heart disease, or if you are a postmenopausal female, discuss these risks with your doctor.

Cardiovascular Risks

Rare but severe and potentially life-threatening heart problems, including heart attack and abnormal heartbeat, have occurred within a few hours of taking this medication. Seek immediate medical attention if you experience:
+ Chest, throat, neck, or jaw tightness, pain, pressure, or heaviness
+ Cold sweats
+ Shortness of breath
+ Rapid or irregular heartbeat
+ Severe dizziness or fainting

Additional Warnings

If you have a latex allergy, inform your doctor, as some products may contain latex.
If you are 65 years or older, use this medication with caution, as you may be more susceptible to side effects.
Pregnant or breastfeeding women should discuss the benefits and risks of this medication with their doctor.

Pediatric Use

* This medication is not approved for use in children. However, your doctor may decide that the benefits of treatment outweigh the risks. If your child has been prescribed this medication, ask your doctor about the potential benefits and risks, and discuss any concerns you may have.
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Overdose Information

Overdose Symptoms:

  • Convulsions
  • Tremor
  • Inactivity
  • Redness of extremities
  • Reduced activity
  • Respiratory depression
  • Ptosis
  • Lacrimation
  • Salivation

What to Do:

There is no specific antidote for sumatriptan overdose. Treatment should be supportive and symptomatic. Monitor the patient for at least 12 hours or while symptoms persist. Consider activated charcoal if ingestion was recent. Call 1-800-222-1222 (Poison Control Center) for immediate advice.

Drug Interactions

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Contraindicated Interactions

  • Monoamine Oxidase Inhibitors (MAOIs) or within 2 weeks of discontinuing MAOIs
  • Ergotamine-containing medications or ergot-type drugs (e.g., dihydroergotamine) or within 24 hours of sumatriptan
  • Other 5-HT1 agonists (triptans) or within 24 hours of sumatriptan
  • Severe hepatic impairment
  • Ischemic heart disease (e.g., angina pectoris, history of myocardial infarction, documented silent ischemia)
  • Coronary artery vasospasm (Prinzmetal's angina)
  • Wolff-Parkinson-White Syndrome or other cardiac accessory conduction pathway disorders
  • History of stroke or transient ischemic attack (TIA)
  • Peripheral vascular disease
  • Uncontrolled hypertension
  • Hemiplegic or basilar migraine
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Major Interactions

  • Selective Serotonin Reuptake Inhibitors (SSRIs)
  • Serotonin Norepinephrine Reuptake Inhibitors (SNRIs)
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Moderate Interactions

  • St. John's Wort
  • Cimetidine (may increase sumatriptan levels, though not clinically significant for injection)
  • Propranolol (may increase sumatriptan levels, though not clinically significant for injection)
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Minor Interactions

  • Alcohol (may exacerbate headache or side effects)

Monitoring

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Baseline Monitoring

Cardiovascular assessment (ECG, blood pressure)

Rationale: To rule out underlying cardiovascular disease, which is a contraindication due to risk of vasospasm.

Timing: Prior to initiating therapy, especially in patients with risk factors for CAD.

Blood pressure

Rationale: To ensure hypertension is controlled, as uncontrolled hypertension is a contraindication.

Timing: Prior to initiating therapy.

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Routine Monitoring

Blood pressure

Frequency: Periodically, especially if patient has risk factors for hypertension.

Target: Normal limits

Action Threshold: Significant increase or uncontrolled hypertension warrants discontinuation.

Headache frequency and severity

Frequency: Ongoing, at each follow-up visit.

Target: Reduction in frequency/severity

Action Threshold: Lack of efficacy or increasing headache frequency (medication overuse headache).

Adverse effects (e.g., chest pain, neck/jaw tightness, paresthesias, dizziness)

Frequency: Ongoing, at each follow-up visit.

Target: Absence or mild, tolerable effects

Action Threshold: Severe or persistent adverse effects, especially those suggestive of cardiac ischemia or neurological events.

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Symptom Monitoring

  • Chest pain or tightness
  • Neck or jaw pain/tightness
  • Shortness of breath
  • Palpitations
  • Dizziness or vertigo
  • Numbness or tingling (paresthesias)
  • Weakness in limbs
  • Vision changes
  • Severe abdominal pain
  • Signs of serotonin syndrome (agitation, hallucinations, rapid heart rate, fever, sweating, muscle rigidity, twitching, coordination problems, nausea, vomiting, diarrhea)

Special Patient Groups

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Pregnancy

Use during pregnancy should only be considered if the potential benefit justifies the potential risk to the fetus. Limited human data suggest no increased risk of major birth defects, but animal studies show some developmental toxicity at high doses.

Trimester-Specific Risks:

First Trimester: Limited human data, no clear evidence of increased risk of major birth defects. Animal studies show some embryolethality and teratogenicity at high doses.
Second Trimester: Limited data, generally considered low risk based on available information.
Third Trimester: Limited data, generally considered low risk based on available information. Potential for vasoconstrictive effects on the fetus is theoretical but not well-studied.
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Lactation

Sumatriptan is excreted into breast milk. The amount ingested by an infant is small (approximately 3.5% of the maternal dose). To minimize infant exposure, breastfeeding can be avoided for 12 hours after sumatriptan administration.

Infant Risk: L3 (Moderate concern). Potential for infant drowsiness, vomiting, or diarrhea. Monitor infant for adverse effects. Consider avoiding breastfeeding for 12 hours post-dose.
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Pediatric Use

Safety and efficacy have not been established in pediatric patients (under 18 years of age) for either migraine or cluster headache. Use is generally not recommended.

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Geriatric Use

Use with caution in elderly patients (over 65 years of age) due to a greater likelihood of decreased renal, hepatic, or cardiac function, and concomitant disease or other drug therapy. Elderly patients may be more sensitive to the effects of sumatriptan, particularly cardiovascular effects. A lower initial dose may be considered, and careful monitoring is advised.

Clinical Information

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Clinical Pearls

  • Sumatriptan injection is often preferred for rapid relief of severe migraine or cluster headache, especially when nausea/vomiting prevent oral administration.
  • Patients should be instructed on proper subcutaneous injection technique.
  • Always rule out cardiovascular disease before prescribing sumatriptan, especially in patients with risk factors.
  • Advise patients to seek immediate medical attention if they experience chest pain, shortness of breath, or other severe symptoms after injection.
  • Headache recurrence is common with triptans; patients may need a second dose or an alternative abortive therapy for recurrent pain.
  • Counsel patients on the risk of serotonin syndrome when co-administered with SSRIs/SNRIs and to report any symptoms immediately.
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Alternative Therapies

  • Other triptans (e.g., zolmitriptan, rizatriptan, eletriptan, frovatriptan, naratriptan, almotriptan) in various formulations (oral, nasal spray, ODT)
  • CGRP receptor antagonists (gepants like rimegepant, ubrogepant)
  • Ditans (lasmiditan)
  • NSAIDs (e.g., ibuprofen, naproxen)
  • Acetaminophen
  • Ergot alkaloids (e.g., ergotamine, dihydroergotamine)
  • Anti-emetics (e.g., metoclopramide, prochlorperazine) for associated nausea/vomiting
  • Opioids (generally not recommended for migraine due to risk of medication overuse headache and dependence)
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Cost & Coverage

Average Cost: Varies widely, typically $50-$150 per 6mg/0.5ml pre-filled syringe per 6mg/0.5ml pre-filled syringe
Generic Available: Yes
Insurance Coverage: Tier 2 or Tier 3 (often requires prior authorization or step therapy for brand, generic is usually preferred)
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General Drug Facts

If your symptoms or health issues persist or worsen, it's essential to contact your doctor for further guidance. To ensure your safety, never share your medication with others or take someone else's medication. Some medications may come with an additional patient information leaflet, so be sure to check with your pharmacist for more information. If you have any questions or concerns about this medication, don't hesitate to reach out to your doctor, nurse, pharmacist, or other healthcare provider. In the event of a suspected overdose, immediately call your local poison control center or seek emergency medical attention. When seeking help, be prepared to provide details about the medication taken, the amount, and the time it happened.