Minocin 50mg Capsules

Manufacturer VALEANT Active Ingredient Minocycline Capsules(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, including skin infections like acne, respiratory infections, and urinary tract infections. It works by stopping the growth of bacteria. It is also sometimes used for other conditions like rheumatoid arthritis.
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How to Use This Medicine

Taking Your Medication Correctly

To get the most benefit from your medication, follow your doctor's instructions carefully. Read all the information provided to you and follow the instructions closely.

Take your medication as directed, swallowing the whole tablet with a full glass of water.
Continue taking your medication even if your symptoms improve.
Take your medication at the same time every day to establish a routine.
You can take your medication with or without food. However, if it causes stomach upset, take it with food to help minimize this side effect.
Avoid taking products containing iron or antacids with aluminum, calcium, or magnesium at the same time as your medication. If you have questions, consult your doctor or pharmacist.

Staying Hydrated

Drink plenty of non-caffeinated liquids, unless your doctor advises you to limit your fluid intake.

Storing and Disposing of Your Medication

Store your medication at room temperature in a dry place, avoiding the bathroom.
Protect your medication from heat and light to preserve its effectiveness.
When you no longer need your medication, dispose of it properly.

Missing a Dose

If you miss a dose, take it as soon as you remember. However, if it's close to the time for your next dose, skip the missed dose and return to your regular schedule. Do not take two doses at the same time or take extra doses to make up for the missed one.
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Lifestyle & Tips

  • Take with a full glass of water to prevent irritation of the esophagus.
  • Avoid lying down for at least 30 minutes after taking the capsule.
  • Avoid taking antacids, iron supplements, or calcium-containing products (like dairy) within 2-3 hours of taking minocycline, as they can reduce its absorption.
  • Protect your skin from the sun and artificial UV light (tanning beds) while taking this medication and for several days after, as it can cause severe sunburn (photosensitivity). Use sunscreen and wear protective clothing.
  • If you are taking oral contraceptives, use an additional non-hormonal birth control method while on minocycline and for 7 days after, as it may reduce the effectiveness of birth control pills.
  • Do not use in children under 8 years of age due to the risk of permanent tooth discoloration.

Dosing & Administration

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Adult Dosing

Standard Dose: 100 mg every 12 hours or 200 mg initially followed by 100 mg every 12 hours, depending on indication. For acne, 50 mg once daily or twice daily.
Dose Range: 50 - 400 mg

Condition-Specific Dosing:

General Infections: 200 mg initially, then 100 mg every 12 hours, or 100 mg every 12 hours.
Acne Vulgaris: 50 mg once daily or 50 mg twice daily.
Gonorrhea (uncomplicated): 200 mg initially, then 100 mg every 12 hours for 4 days.
Syphilis: 200 mg initially, then 100 mg every 12 hours for 10-15 days.
Cholera: 200 mg initially, then 100 mg every 12 hours for 3 days.
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Pediatric Dosing

Neonatal: Not established (contraindicated due to tooth discoloration and bone effects)
Infant: Not established (contraindicated due to tooth discoloration and bone effects)
Child: Not recommended for children under 8 years of age due to permanent tooth discoloration and bone growth inhibition. For children >8 years: 4 mg/kg initially, then 2 mg/kg every 12 hours (max 200 mg/day).
Adolescent: Same as adult dosing for adolescents >8 years and >45 kg.
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Dose Adjustments

Renal Impairment:

Mild: No adjustment needed.
Moderate: No adjustment needed, but monitor for adverse effects.
Severe: Use with caution; consider lower total daily dose or extended dosing intervals. Monitor for increased serum levels and adverse effects.
Dialysis: Minocycline is not significantly removed by hemodialysis. No supplemental dose needed after dialysis, but use with caution and monitor.

Hepatic Impairment:

Mild: Use with caution.
Moderate: Use with caution; consider lower total daily dose or extended dosing intervals. Monitor liver function.
Severe: Use with caution; consider lower total daily dose or extended dosing intervals. Monitor liver function closely.

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: 90-100%
Tmax: 1-4 hours
FoodEffect: Absorption is not significantly affected by food or dairy products, unlike other tetracyclines, but it is still recommended to take with a full glass of water to prevent esophageal irritation.

Distribution:

Vd: Approximately 0.7 L/kg
ProteinBinding: 70-75%
CnssPenetration: Yes (achieves therapeutic concentrations in CSF, tears, and saliva)

Elimination:

HalfLife: 11-22 hours (prolonged in renal impairment)
Clearance: Not readily available, but primarily renal and fecal excretion.
ExcretionRoute: Renal (5-10% unchanged) and fecal/biliary (major route)
Unchanged: Approximately 5-10% (renal)
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Pharmacodynamics

OnsetOfAction: Within hours (antibacterial effect)
PeakEffect: Within 1-4 hours (plasma concentration)
DurationOfAction: 24 hours (due to long half-life, allowing once or twice daily dosing)

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 immediately or seek emergency medical attention:

Signs of an allergic reaction, such as:
+ Rash or hives
+ Itching or red, swollen, blistered, or peeling skin (with or without fever)
+ Wheezing or tightness in the chest or throat
+ Difficulty breathing, swallowing, or talking
+ Unusual hoarseness
+ Swelling of the mouth, face, lips, tongue, or throat
Signs of pancreatitis (pancreas problems), such as:
+ Severe stomach pain
+ Severe back pain
+ Severe upset stomach or vomiting
Signs of kidney problems, such as:
+ Inability to urinate
+ Changes in urine output
+ Blood in the urine
+ Sudden weight gain
Signs of lupus, such as:
+ Rash on the cheeks or other body parts
+ Easy sunburn
+ Muscle or joint pain
+ Chest pain or shortness of breath
+ Swelling in the arms or legs
Fever, chills, or sore throat
Unexplained bruising or bleeding
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 (darkening)
Mouth irritation or mouth sores
Burning, numbness, or tingling sensations
Redness or white patches in the mouth or throat
Rectal or genital irritation
Vaginal itching or discharge
Diarrhea (common with antibiotics, but rarely, a severe form called C. diff-associated diarrhea (CDAD) may occur, which can lead to a life-threatening bowel problem)
Stomach pain, cramps, or loose, watery, or bloody stools (if you experience these symptoms, contact your doctor immediately)
Liver problems, such as:
+ Dark urine
+ Fatigue
+ Decreased appetite
+ Upset stomach or stomach pain
+ Light-colored stools
+ Vomiting
+ Yellow skin or eyes
Raised pressure in the brain, which may cause:
+ Headache
+ Vision problems (blurred vision, double vision, or loss of vision)
Thyroid cancer (long-term use of this medication has been associated with an increased risk of thyroid cancer; contact your doctor if you notice:
+ Lasting hoarseness
+ Neck mass
+ Difficulty breathing or swallowing
Severe skin reactions, such as:
+ Stevens-Johnson syndrome (SJS)
+ Toxic epidermal necrolysis (TEN)
+ Other serious reactions (which can affect body organs and be life-threatening)
+ Signs of these reactions include:
- 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
- Swollen glands

Other Possible Side Effects

While many people may not experience any side effects or only minor ones, it's essential to be aware of the following:

Diarrhea
Upset stomach or vomiting
Decreased appetite
Dizziness, drowsiness, tiredness, or weakness

If you experience any of these side effects or any other unusual symptoms, contact your doctor or seek medical attention. Not all side effects are listed here, so if you have concerns, don't hesitate to reach out to your doctor.

Reporting Side Effects

You can 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, blurred vision, double vision, or vision loss (could be signs of increased pressure in the brain, pseudotumor cerebri). Seek immediate medical attention.
  • Severe dizziness or lightheadedness, especially when standing up.
  • Severe skin rash, blistering, peeling skin, or swelling of the face, lips, tongue, or throat (signs of severe allergic reaction or DRESS syndrome). Seek immediate medical attention.
  • Yellowing of the skin or eyes, dark urine, severe stomach pain, or persistent nausea/vomiting (signs of liver problems).
  • Unusual bleeding or bruising, persistent sore throat, fever, or unusual tiredness (signs of blood problems).
  • Severe diarrhea that is watery or bloody (could be C. difficile infection).
  • Joint pain, muscle aches, fever, and rash (could be drug-induced lupus-like syndrome).
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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 symptoms you experienced.
If you are currently taking any of the following medications: Acitretin, Isotretinoin, or a Penicillin.
* If you are breastfeeding or plan to breastfeed, as you may need to avoid breastfeeding while taking this medication.

This list is not exhaustive, and it is crucial to discuss all your medications (including 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 with your other medications and health conditions.

Remember, do not start, stop, or change the dose 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. Before engaging in activities that require your full attention, such as driving, wait until you understand how this drug affects you. As directed by your doctor, have your blood work checked regularly and discuss the results with your doctor.

This medication may interfere with certain laboratory tests, so be sure to notify all your healthcare providers and laboratory personnel that you are taking this drug. Do not exceed the prescribed duration of treatment, as this may increase the risk of a second infection.

When taking this medication, exercise caution when exposed to sunlight, as it may increase your susceptibility to sunburn. If you experience unusual sunburn, inform your doctor. Typically, this medication is not recommended for children under 8 years old, but in some cases, it may be necessary. Consult with your doctor to discuss the potential risks and benefits.

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 be irreversible. However, in adults, tooth discoloration has been reported to be reversible after stopping the medication and undergoing dental cleaning. Discuss any concerns with your doctor.

If you are using birth control pills or other hormone-based birth control methods, be aware that this medication may reduce their effectiveness. Consider using an additional form of birth control, such as a condom, to prevent pregnancy. If you are pregnant or become pregnant while taking this medication, contact your doctor immediately, as it may harm the unborn baby.
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Overdose Information

Overdose Symptoms:

  • Nausea
  • Vomiting
  • Diarrhea
  • Dizziness
  • Lightheadedness

What to Do:

In case of overdose, seek immediate medical attention or call Poison Control at 1-800-222-1222. Treatment is generally supportive, including gastric lavage if ingestion is recent. Hemodialysis is not effective in removing minocycline.

Drug Interactions

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Major Interactions

  • Isotretinoin (increased risk of pseudotumor cerebri)
  • Oral Retinoids (e.g., acitretin, tretinoin) (increased risk of pseudotumor cerebri)
  • Methoxyflurane (fatal renal toxicity)
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Moderate Interactions

  • Antacids containing aluminum, calcium, or magnesium (decreased minocycline absorption)
  • Iron preparations (decreased minocycline absorption)
  • Bismuth subsalicylate (decreased minocycline absorption)
  • Oral contraceptives (decreased efficacy of oral contraceptives, increased risk of breakthrough bleeding)
  • Anticoagulants (e.g., warfarin) (potentiates anticoagulant effect)
  • Penicillins (may interfere with bactericidal action of penicillin)
  • Ergot alkaloids (increased risk of ergotism)
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Minor Interactions

  • Digoxin (may increase digoxin levels in some patients)

Monitoring

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Baseline Monitoring

Liver function tests (ALT, AST, bilirubin)

Rationale: To establish baseline and identify pre-existing hepatic impairment, as minocycline can cause hepatotoxicity.

Timing: Prior to initiation, especially in patients with pre-existing liver disease.

Renal function tests (BUN, creatinine)

Rationale: To establish baseline and identify pre-existing renal impairment, though minocycline is primarily excreted fecally, caution is advised in severe renal dysfunction.

Timing: Prior to initiation, especially in patients with pre-existing renal disease.

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Routine Monitoring

Liver function tests (ALT, AST, bilirubin)

Frequency: Periodically, especially with prolonged therapy or in patients with hepatic impairment.

Target: Within normal limits or stable from baseline.

Action Threshold: Significant elevation (e.g., >3x ULN) warrants discontinuation and investigation.

Renal function tests (BUN, creatinine)

Frequency: Periodically, especially with prolonged therapy or in patients with severe renal impairment.

Target: Within normal limits or stable from baseline.

Action Threshold: Significant elevation warrants dose adjustment or discontinuation.

Complete Blood Count (CBC)

Frequency: Periodically with long-term therapy (e.g., for acne).

Target: Within normal limits.

Action Threshold: Significant abnormalities (e.g., neutropenia, thrombocytopenia) warrant investigation and discontinuation.

Intracranial pressure (symptoms)

Frequency: Ongoing clinical assessment.

Target: N/A

Action Threshold: Headache, blurred vision, diplopia, or vision loss warrant immediate evaluation for pseudotumor cerebri.

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Symptom Monitoring

  • Dizziness
  • Vertigo
  • Nausea
  • Vomiting
  • Diarrhea
  • Photosensitivity (severe sunburn-like reaction)
  • Skin discoloration (blue-gray pigmentation)
  • Tooth discoloration (in children)
  • Headache
  • Blurred vision
  • Diplopia
  • Vision loss (signs of pseudotumor cerebri)
  • Joint pain
  • Muscle aches
  • Fever
  • Rash (signs of drug-induced lupus or DRESS syndrome)

Special Patient Groups

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Pregnancy

Minocycline is 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 reversible inhibition of bone growth in the fetus.

Trimester-Specific Risks:

First Trimester: Potential for skeletal and dental effects, though risk is higher in later trimesters.
Second Trimester: High risk of permanent tooth discoloration (yellow-gray-brown) and inhibition of bone growth.
Third Trimester: High risk of permanent tooth discoloration (yellow-gray-brown) and inhibition of bone growth.
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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. The American Academy of Pediatrics considers tetracyclines to be compatible with breastfeeding with caution, but minocycline's longer half-life and higher lipid solubility may increase infant exposure compared to other tetracyclines.

Infant Risk: L3 (Moderately Safe - Possible risk to infant; use only if benefit outweighs risk).
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Pediatric Use

Contraindicated in children under 8 years of age due to the risk of permanent tooth discoloration (yellow-gray-brown) and reversible inhibition of bone growth. Use in children >8 years should be carefully considered and only when other antibiotics are not appropriate.

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Geriatric Use

No specific dose adjustment is generally required based on age alone. However, elderly patients may be more susceptible to adverse effects such as dizziness/vertigo and may have age-related renal or hepatic impairment requiring caution and monitoring.

Clinical Information

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Clinical Pearls

  • Minocycline is unique among tetracyclines for its better CNS penetration and less significant interaction with food/dairy products regarding absorption.
  • It is often preferred for acne due to its anti-inflammatory properties in addition to its antibacterial effects.
  • Counsel patients extensively on photosensitivity and the need for sun protection.
  • Warn patients about potential for dizziness/vertigo, especially at the start of therapy, and advise caution with driving or operating machinery.
  • Be aware of the potential for blue-gray skin, nail, or gum discoloration with long-term use, which can be permanent.
  • Monitor for signs of drug-induced lupus erythematosus or DRESS syndrome, especially with prolonged use.
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Alternative Therapies

  • Doxycycline (another tetracycline, often used for similar indications)
  • Tetracycline (another tetracycline)
  • Erythromycin (for acne, if tetracyclines are contraindicated)
  • Clindamycin (for acne, topical or oral)
  • Trimethoprim/sulfamethoxazole (for certain bacterial infections)
  • Amoxicillin (for certain bacterial infections)
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Cost & Coverage

Average Cost: Not available per 30 tablets
Generic Available: Yes
Insurance Coverage: Tier 1 or 2 (generic)
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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 medical attention. When seeking help, be prepared to provide details about the medication taken, the amount, and the time it occurred.