Minocin 100mg Inj, 1 Vial

Manufacturer MELINTA THERAPEUTICS Active Ingredient Minocycline Injection(mi noe SYE kleen) Pronunciation mi noe SYE kleen
It is used to treat or prevent bacterial infections.It is used to treat pimples (acne).It may be given to you for other reasons. Talk with the doctor.
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Drug Class
Antibiotic
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Pharmacologic Class
Tetracycline Antibiotic
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Pregnancy Category
Category D
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FDA Approved
Jun 1971
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DEA Schedule
Not Controlled

Overview

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What is this medicine?

Minocycline is an antibiotic used to treat various bacterial infections. It works by stopping the growth of bacteria. Since this is an injection, it will be given by a healthcare professional, usually in a hospital or clinic setting.
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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 adhere to all guidelines provided. This drug is administered via infusion into a vein over a specified period of time.

For storage and disposal, consult with your doctor, nurse, or pharmacist to determine the best approach if you need to keep this medication at home.

If you miss a dose, contact your doctor immediately to receive guidance on the next steps to take.
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Lifestyle & Tips

  • Avoid prolonged exposure to sunlight or tanning beds, as minocycline can make your skin more sensitive to the sun (photosensitivity). Use sunscreen and wear protective clothing when outdoors.
  • Report any unusual or severe headaches, vision changes, or dizziness immediately to your doctor.
  • If you experience severe diarrhea, especially if it's watery or bloody, contact your doctor as it could be a sign of a serious infection (C. difficile).

Dosing & Administration

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Adult Dosing

Standard Dose: Initial dose of 200 mg, then 100 mg every 12 hours
Dose Range: 100 - 200 mg

Condition-Specific Dosing:

Severe Infections: Initial 200 mg, then 100 mg every 12 hours. Max 400 mg/day.
Acinetobacter Infections: Higher doses may be considered in some cases, up to 200 mg every 12 hours, but standard dosing is usually sufficient.
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Pediatric Dosing

Neonatal: Not established (contraindicated due to tooth discoloration and bone growth effects)
Infant: Not established (contraindicated due to tooth discoloration and bone growth effects)
Child: Not recommended for children under 8 years of age due to permanent tooth discoloration and bone growth effects. For children 8 years and older: 4 mg/kg initial dose, then 2 mg/kg every 12 hours. Max 200 mg/day.
Adolescent: For adolescents 8 years and older: 4 mg/kg initial dose, then 2 mg/kg every 12 hours. Max 200 mg/day. Or adult dosing if weight appropriate.
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Dose Adjustments

Renal Impairment:

Mild: No specific adjustment needed, but monitor for increased side effects.
Moderate: Consider dose reduction or increased dosing interval (e.g., 100 mg every 24 hours) if creatinine clearance is <80 mL/min. Monitor serum levels if possible.
Severe: Consider dose reduction or increased dosing interval (e.g., 100 mg every 24 hours) if creatinine clearance is <80 mL/min. Monitor serum levels if possible.
Dialysis: Minocycline is not significantly removed by hemodialysis. Administer dose after dialysis. Monitor for increased side effects.

Hepatic Impairment:

Mild: Use with caution. No specific dose adjustment recommended, but monitor for increased side effects.
Moderate: Use with caution. No specific dose adjustment recommended, but monitor for increased side effects.
Severe: Use with caution. No specific dose adjustment recommended, but monitor for increased side effects. Avoid if possible.

Pharmacology

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Mechanism of Action

Minocycline is a tetracycline antibiotic that inhibits bacterial protein synthesis by reversibly binding to the 30S ribosomal subunit, thereby preventing the attachment of aminoacyl-tRNA to the ribosomal acceptor site. This action prevents the addition of new amino acids to the growing peptide chain, leading to bacteriostasis.
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Pharmacokinetics

Absorption:

Bioavailability: Not applicable for IV injection (100% bioavailability)
Tmax: Not applicable for IV injection (peak concentration achieved rapidly)
FoodEffect: Not applicable for IV injection

Distribution:

Vd: Approximately 1.6 L/kg
ProteinBinding: 70-75%
CnssPenetration: Yes (achieves therapeutic concentrations in CSF, especially with inflamed meninges)

Elimination:

HalfLife: 11-22 hours (prolonged in renal impairment)
Clearance: Not readily available for IV, but primarily renal and fecal excretion.
ExcretionRoute: Renal (10-30%) and fecal (biliary excretion and enterohepatic recirculation)
Unchanged: Approximately 10-30% renally excreted unchanged
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Pharmacodynamics

OnsetOfAction: Rapid
PeakEffect: Within minutes of IV infusion completion
DurationOfAction: Due to long half-life, allows for twice-daily dosing.
Confidence: High

Safety & Warnings

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Side Effects

Urgent Side Effects: Seek Medical Help Right Away

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 immediately:

Signs of an allergic reaction: 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, or swelling of the mouth, face, lips, tongue, or throat.
Signs of pancreatitis (pancreas problem): severe stomach pain, severe back pain, or severe upset stomach or vomiting.
Signs of kidney problems: inability to pass urine, changes in urine output, blood in the urine, or significant weight gain.
Signs of lupus: rash on the cheeks or other body parts, easy sunburn, muscle or joint pain, chest pain or shortness of breath, or swelling in the arms or legs.
Fever, chills, or sore throat.
Unexplained bruising or bleeding, or feeling extremely tired or weak.
Changes in hearing.
Joint pain or swelling.
Muscle pain or weakness.
Ringing in the ears.
Seizures.
Shortness of breath.
Chest pain.
Abnormal heartbeat.
Swelling.
Changes in nail, skin, eye, scar, tooth, or gum color to a darker shade.
Mouth irritation or mouth sores.
Burning, numbness, or tingling sensations that are not normal.
Redness or white patches in the mouth or throat.
Rectal or genital irritation.
Vaginal itching or discharge.
Flushing.
Excessive sweating.
Severe dizziness or fainting.
Difficulty moving around.
Feeling cold.
Diarrhea (common with antibiotics), especially if severe, watery, or bloody (may be a sign of C. difficile-associated diarrhea, a potentially life-threatening condition).
Liver problems: dark urine, tiredness, decreased appetite, upset stomach or stomach pain, light-colored stools, vomiting, or yellow skin or eyes.
Raised pressure in the brain: headache or eyesight problems like blurred vision, double vision, or loss of vision.
Thyroid cancer symptoms: lasting hoarseness, neck mass, or trouble breathing or swallowing.
Severe skin reactions (Stevens-Johnson syndrome, toxic epidermal necrolysis, or other serious reactions): red, swollen, blistered, or peeling skin; red or irritated eyes; sores in the mouth, throat, nose, eyes, genitals, or skin; fever; chills; body aches; shortness of breath; or swollen glands.

Other Side Effects

Most people experience no side effects or only mild side effects while taking this medication. However, if you notice any of the following side effects or any other unusual symptoms, contact your doctor or seek medical attention:

Diarrhea, upset stomach, or vomiting.
Decreased appetite.
Dizziness, drowsiness, tiredness, or weakness.
* Irritation at the injection site.

This is not an exhaustive list of possible side effects. If you have questions or concerns about side effects, consult 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:

  • Severe headache, especially with blurred vision or double vision
  • Dizziness or lightheadedness
  • Nausea, vomiting, or severe diarrhea
  • Unusual tiredness or weakness
  • Yellowing of the skin or eyes (jaundice)
  • Dark urine or pale stools
  • Severe skin rash, blistering, or peeling
  • Joint pain, muscle aches, or fever (signs of drug-induced lupus)
  • Signs of allergic reaction (e.g., rash, itching, swelling of face/throat, severe dizziness, trouble 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. Be sure to describe the allergic reaction you experienced, including any symptoms that occurred.
If you are currently taking any of the following medications: Acitretin, Isotretinoin, or a Penicillin.
* If you are breast-feeding or plan to breast-feed, as you may need to avoid nursing while taking this medication.

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. Additionally, inform them about any existing health problems.

To ensure your safety, always verify with your doctor that it is safe to take this medication with your other medications and health conditions. Never start, stop, or change the dosage of any medication without first consulting your doctor.
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Precautions & Cautions

It is essential to inform all your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are taking this medication. This will help ensure your safety and prevent any potential interactions.

Until you know how this medication affects you, avoid driving and other activities that require alertness. Your doctor will also instruct you to have regular blood tests to monitor your condition. Be sure to follow their instructions and discuss any concerns with them.

This medication may interfere with certain laboratory tests, so it's crucial to inform all your healthcare providers and lab personnel that you are taking it. Do not take this medication for longer than prescribed, as this may increase the risk of a second infection.

You may be more susceptible to sunburn while taking this medication, so take precautions when spending time outdoors. If you experience easy sunburning, notify your doctor.

In children under 8 years old, this medication may cause a permanent change in tooth color, resulting in a yellow-gray-brown discoloration. If this occurs, the change will not reverse. Discuss the risks and benefits with your doctor, as this medication is typically not recommended for children under 8 years old. However, in some cases, your doctor may prescribe it for younger children.

Although less common, tooth discoloration has also been reported in adults taking this medication. In these cases, the change in tooth color typically reverses after stopping the medication and undergoing a professional dental cleaning. Consult your doctor if you have concerns.

If you are using birth control pills or other hormone-based contraception, you should be aware that this medication may reduce their effectiveness. To prevent pregnancy, use an additional form of birth control, such as a condom, while taking this medication.

It is also important to note that this medication may harm an unborn baby if taken during pregnancy. If you become pregnant or suspect you may be pregnant while taking this medication, contact your doctor immediately.
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Overdose Information

Overdose Symptoms:

  • Nausea
  • Vomiting
  • Diarrhea
  • Dizziness
  • Lightheadedness

What to Do:

Seek immediate medical attention or call a poison control center (1-800-222-1222). Treatment is supportive; hemodialysis is not effective.

Drug Interactions

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Major Interactions

  • Antacids containing aluminum, calcium, or magnesium (oral forms - chelation, reduced absorption if given concurrently with oral minocycline, less relevant for IV but still caution if patient is on oral antacids)
  • Iron preparations (oral forms - chelation, reduced absorption if given concurrently with oral minocycline, less relevant for IV)
  • Oral retinoids (e.g., isotretinoin, acitretin) - increased risk of pseudotumor cerebri
  • Penicillins (bacteriostatic tetracyclines may interfere with the bactericidal action of penicillins)
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Moderate Interactions

  • Oral anticoagulants (e.g., warfarin) - tetracyclines may depress plasma prothrombin activity, requiring dose adjustment of anticoagulant
  • Oral contraceptives - may reduce efficacy of oral contraceptives (though evidence is weak, advise backup method)
  • Ergot alkaloids (theoretical increased risk of ergotism)
  • Methoxyflurane (increased risk of nephrotoxicity)
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Minor Interactions

  • Digoxin (may increase digoxin absorption in some patients)

Monitoring

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Baseline Monitoring

Renal function (BUN, creatinine)

Rationale: To assess baseline kidney function and guide dosing, especially in patients with pre-existing impairment.

Timing: Prior to initiation of therapy

Hepatic function (ALT, AST, bilirubin)

Rationale: To assess baseline liver function, as minocycline is metabolized in the liver and can cause hepatotoxicity.

Timing: Prior to initiation of therapy

Complete Blood Count (CBC)

Rationale: To assess baseline hematologic status, as tetracyclines can rarely cause hematologic abnormalities.

Timing: Prior to initiation of therapy

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Routine Monitoring

Renal function (BUN, creatinine)

Frequency: Periodically, especially in prolonged therapy or renal impairment

Target: Within normal limits or stable from baseline

Action Threshold: Significant increase from baseline or worsening renal function

Hepatic function (ALT, AST, bilirubin)

Frequency: Periodically, especially in prolonged therapy or if signs of liver dysfunction develop

Target: Within normal limits or stable from baseline

Action Threshold: Significant increase from baseline (e.g., >3x ULN) or signs of liver injury

Signs/symptoms of pseudotumor cerebri (e.g., headache, blurred vision, papilledema)

Frequency: Throughout therapy

Target: Absence of symptoms

Action Threshold: Development of new or worsening symptoms

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Symptom Monitoring

  • Headache (especially severe or persistent)
  • Blurred vision or other visual disturbances
  • Dizziness or vertigo
  • Nausea, vomiting, diarrhea
  • Skin rash, photosensitivity reactions (sunburn-like reaction)
  • Signs of superinfection (e.g., oral thrush, vaginal yeast infection, severe diarrhea/C. difficile)
  • Signs of drug-induced lupus erythematosus (e.g., arthralgia, myalgia, rash, fever)

Special Patient Groups

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Pregnancy

Minocycline is classified as Pregnancy Category D. It should not be used during pregnancy unless the potential benefit justifies the potential risk to the fetus. Tetracyclines can cause permanent discoloration of teeth (yellow-gray-brown) and inhibition of bone growth in the fetus when administered during the last half of pregnancy.

Trimester-Specific Risks:

First Trimester: Limited data, but potential for teratogenicity cannot be excluded. Avoid if possible.
Second Trimester: Risk of permanent tooth discoloration and inhibition of bone growth in the fetus.
Third Trimester: Risk of permanent tooth discoloration and inhibition of bone growth in the fetus.
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Lactation

Minocycline is excreted into breast milk. Due to the potential for serious adverse reactions in the nursing infant, including tooth discoloration and inhibition of bone growth, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.

Infant Risk: L3 - Moderate risk. Potential for tooth discoloration, enamel hypoplasia, and inhibition of bone growth in the infant. Monitor infant for diarrhea, candidiasis, and rash.
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Pediatric Use

Minocycline is generally not recommended for use in children under 8 years of age due to the risk of permanent tooth discoloration (yellow-gray-brown) and inhibition of bone growth. In children 8 years and older, it should be used with caution and only when other antibiotics are not suitable.

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Geriatric Use

No specific dose adjustment is generally required based on age alone. However, elderly patients are more likely to have age-related decreases in renal or hepatic function, which may necessitate dose adjustments or closer monitoring. They may also be more susceptible to side effects like dizziness/vertigo.

Clinical Information

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Clinical Pearls

  • Minocycline IV should be administered by slow intravenous infusion, usually over 1 hour, to minimize the risk of dizziness/vertigo.
  • Unlike some other tetracyclines, minocycline can be taken with food (oral form) as its absorption is less affected, but this is not relevant for the IV form.
  • Minocycline has good tissue penetration, including into the CSF, skin, and prostate.
  • It is often used for infections caused by multidrug-resistant organisms, including some strains of Acinetobacter baumannii and MRSA, though resistance patterns vary geographically.
  • Patients should be advised about photosensitivity and to use sun protection.
  • Be aware of the potential for drug-induced lupus erythematosus, which can occur after prolonged therapy (months to years) and is usually reversible upon discontinuation.
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Alternative Therapies

  • Doxycycline (another tetracycline, often preferred due to lower incidence of vestibular side effects)
  • Tigecycline (a glycylcycline, structurally related to tetracyclines, often used for resistant infections)
  • Other broad-spectrum antibiotics depending on the specific infection and susceptibility (e.g., carbapenems, polymyxins, cephalosporins, fluoroquinolones, vancomycin)
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Cost & Coverage

Average Cost: Varies widely, typically $50 - $200 per 100mg vial per 100mg vial
Generic Available: Yes
Insurance Coverage: Tier 2 or 3 (generic often Tier 1 or 2)
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General Drug Facts

If your symptoms or health problems persist or worsen, it is essential to contact your doctor for further guidance. To ensure safe use, never share your medication with others, and do not take medication prescribed for someone else. Store all medications in a secure location, out of reach of children and pets, to prevent accidental ingestion. Dispose of unused or expired medications properly. Unless instructed to do so by a healthcare professional, do not flush medications down the toilet or pour them down the drain. If you are unsure about the proper disposal method, consult your pharmacist for guidance. Many communities offer drug take-back programs, which your pharmacist can help you locate. Some medications may come with an additional patient information leaflet; check with your pharmacist to see if this applies to your prescription. If you have any questions or concerns about your medication, discuss them with your doctor, nurse, pharmacist, or other healthcare provider. In the event of a suspected overdose, immediately contact your local poison control center or seek emergency medical attention. Be prepared to provide information about the medication taken, the amount, and the time it was taken to ensure prompt and effective treatment.