Minocin 75mg 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 severe acne. It works by stopping the growth of bacteria. It's important to take it exactly as prescribed and be aware of potential side effects like sun sensitivity and dizziness.
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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 tablet whole 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.

What to Do If You Miss 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

  • Avoid prolonged exposure to sunlight or tanning beds; use sunscreen and wear protective clothing due to increased risk of severe sunburn (photosensitivity).
  • Avoid taking antacids, iron supplements, calcium supplements, or dairy products within 2-3 hours of taking minocycline, as they can interfere with absorption.
  • If you experience dizziness or lightheadedness, avoid driving or operating heavy machinery.
  • Stay well-hydrated to prevent esophageal irritation.

Dosing & Administration

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Adult Dosing

Standard Dose: For general infections: 200 mg initially, then 100 mg every 12 hours. For acne: 50 mg once or twice daily, or 1.3 mg/kg once daily.
Dose Range: 50 - 400 mg

Condition-Specific Dosing:

Acne Vulgaris: 50 mg once or twice daily, or 1.3 mg/kg once daily (e.g., 75 mg once daily for a 58 kg person).
Bacterial Infections: 200 mg initially, then 100 mg every 12 hours. Max 400 mg/day.
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Pediatric Dosing

Neonatal: Not established (contraindicated in children under 8 years due to tooth discoloration and bone growth effects).
Infant: Not established (contraindicated in children under 8 years).
Child: Not established (contraindicated in children under 8 years). For children 8 years and older: 4 mg/kg initially, then 2 mg/kg every 12 hours. Max 200 mg/day.
Adolescent: For adolescents 8 years and older: 4 mg/kg initially, then 2 mg/kg every 12 hours. Max 200 mg/day. For acne: 50 mg once or twice daily, or 1.3 mg/kg once daily.
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Dose Adjustments

Renal Impairment:

Mild: No specific adjustment needed.
Moderate: No specific adjustment needed, but monitor for adverse effects.
Severe: Use with caution; minocycline is primarily eliminated via non-renal routes, but accumulation can occur. Monitor for adverse effects.
Dialysis: Minocycline is not significantly removed by hemodialysis. No specific supplemental dose needed, but use with caution and monitor.

Hepatic Impairment:

Mild: No specific adjustment needed.
Moderate: Use with caution; monitor for signs of hepatotoxicity.
Severe: Use with caution; monitor for signs of hepatotoxicity and consider dose reduction if adverse effects occur.

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 amino acids to the growing peptide chain, leading to bacteriostasis.
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Pharmacokinetics

Absorption:

Bioavailability: 90-100%
Tmax: 1-4 hours
FoodEffect: Food, including dairy products, and antacids containing polyvalent cations (aluminum, calcium, magnesium) can decrease absorption, but less so than with other tetracyclines. It is generally recommended to take minocycline on an empty stomach or at least 1-2 hours before or after meals/dairy/antacids for optimal absorption.

Distribution:

Vd: 1.3 L/kg
ProteinBinding: 70-75%
CnssPenetration: Yes (achieves therapeutic concentrations in CSF, especially with inflamed meninges)

Elimination:

HalfLife: 11-22 hours (average 15 hours)
Clearance: Not readily available, but primarily non-renal.
ExcretionRoute: Fecal (major route, via biliary excretion), renal (minor route, 5-10% unchanged drug)
Unchanged: 5-10% (renal)
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Pharmacodynamics

OnsetOfAction: Rapid (antibacterial effects within hours of achieving therapeutic concentrations)
PeakEffect: Correlates with Tmax (1-4 hours)
DurationOfAction: Due to its long half-life, allows for once or twice daily dosing.

Safety & Warnings

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Side Effects

Urgent Side Effects: Seek Medical Help Right Away

While rare, some people may experience severe and potentially life-threatening side effects when taking this medication. If you notice any of the following symptoms, contact your doctor or seek medical attention immediately:

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
+ Trouble breathing, swallowing, or talking
+ Unusual hoarseness
+ Swelling of the mouth, face, lips, tongue, or throat
Signs of pancreatitis (pancreas problem), such as:
+ Severe stomach pain
+ Severe back pain
+ Severe upset stomach or vomiting
Signs of kidney problems, such as:
+ Inability to pass urine
+ 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 sunburning
+ 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 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 before treating diarrhea)

Additional Serious Side Effects

Liver problems (which can be life-threatening): Contact your doctor immediately if you experience dark urine, tiredness, decreased appetite, upset stomach or stomach pain, light-colored stools, vomiting, or yellow skin or eyes.
Raised pressure in the brain: This condition usually resolves after stopping the medication, but in some cases, it can lead to permanent vision loss. Seek medical help right away if you experience headaches or vision problems, such as blurred vision, double vision, or loss of vision.
Thyroid cancer: Although rare, long-term use of this medication has been associated with an increased risk of thyroid cancer. Contact your doctor immediately if you notice lasting hoarseness, a neck mass, or trouble breathing or swallowing.
Severe skin reactions (including Stevens-Johnson syndrome, toxic epidermal necrolysis, and other serious reactions): These conditions can be life-threatening and may affect other organs. Seek medical help right away if you experience:
+ 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 Side Effects

While many people do not experience side effects or only have mild side effects, it is 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 symptoms that concern you, contact your doctor or seek medical attention. 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, blurred vision, double vision, or vision loss (signs of pseudotumor cerebri)
  • Yellowing of skin or eyes, dark urine, persistent nausea/vomiting, severe stomach pain (signs of liver problems)
  • Unusual bleeding or bruising, persistent sore throat, fever (signs of blood disorders)
  • Severe skin rash, fever, swollen lymph nodes, swelling of face/lips/tongue (signs of severe allergic reaction or DRESS syndrome)
  • Joint pain, rash, fever, fatigue (signs of drug-induced lupus)
  • Severe dizziness or vertigo
  • New or worsening blue-gray skin discoloration
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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 and over-the-counter drugs, natural products, and vitamins, with your doctor and pharmacist. They will help determine if it is safe to take this medication with your existing medications and health conditions.

Remember, do not start, stop, or change the dose of any medication without first consulting your doctor to ensure your safety.
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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 alertness, such as driving, wait until you understand how this drug affects you. As directed by your doctor, undergo regular blood tests and discuss the results with them.

This medication may interfere with certain laboratory tests, so it is crucial 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 secondary infection.

When taking this medication, be cautious 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 permanent tooth discoloration, resulting in a yellow-gray-brown color. If this occurs, the change is irreversible. However, in adults, tooth discoloration has been reported to be reversible after discontinuing the medication and undergoing dental cleaning. Discuss any concerns with your doctor.

When taking this medication, birth control pills and other hormone-based contraceptives may be less effective. To prevent pregnancy, use an additional form of birth control, such as condoms. If you are pregnant or become pregnant while taking this medication, immediately contact your doctor, as it may harm the unborn baby.
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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; gastric lavage may be indicated if ingestion is recent. Hemodialysis is not effective.

Drug Interactions

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Contraindicated Interactions

  • Isotretinoin (and other oral retinoids): Increased risk of pseudotumor cerebri (benign intracranial hypertension).
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Major Interactions

  • Antacids (containing aluminum, calcium, magnesium), iron preparations, bismuth subsalicylate, zinc supplements: Decreased absorption of minocycline due to chelation. Separate administration by at least 2-3 hours.
  • Oral anticoagulants (e.g., Warfarin): May potentiate anticoagulant effect. Monitor INR/PT closely.
  • Penicillins: Tetracyclines are bacteriostatic and may interfere with the bactericidal action of penicillins. Avoid concomitant use if possible, especially in serious infections.
  • Ergot alkaloids: Theoretical increased risk of ergotism.
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Moderate Interactions

  • Oral contraceptives: Theoretical decreased efficacy of oral contraceptives due to altered gut flora. Advise backup contraception.
  • Methotrexate: May increase methotrexate toxicity due to competition for renal excretion.
  • Live bacterial vaccines (e.g., Typhoid vaccine): May reduce the therapeutic effect of the vaccine. Administer minocycline at least 24 hours after vaccine.
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Minor Interactions

  • Not available

Monitoring

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Baseline Monitoring

Liver function tests (LFTs)

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

Timing: Prior to initiation, especially for long-term therapy.

Renal function (BUN, creatinine)

Rationale: To establish baseline, although minocycline is primarily non-renally eliminated, caution is advised in severe renal impairment.

Timing: Prior to initiation, especially for long-term therapy or in patients with known renal issues.

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Routine Monitoring

Liver function tests (LFTs)

Frequency: Periodically, especially during prolonged therapy (e.g., every 3-6 months for acne).

Target: Within normal limits.

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

Complete Blood Count (CBC)

Frequency: Periodically, especially during prolonged therapy (e.g., every 3-6 months for acne).

Target: Within normal limits.

Action Threshold: Significant abnormalities (e.g., leukopenia, thrombocytopenia) warrant discontinuation.

Renal function (BUN, creatinine)

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

Target: Within normal limits.

Action Threshold: Significant worsening may require re-evaluation of therapy.

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Symptom Monitoring

  • Signs of hepatotoxicity (e.g., jaundice, dark urine, persistent nausea/vomiting, abdominal pain)
  • Signs of pseudotumor cerebri (e.g., severe headache, blurred vision, diplopia, papilledema)
  • Signs of photosensitivity (e.g., severe sunburn reaction)
  • Signs of drug-induced lupus (e.g., arthralgia, rash, fever)
  • Signs of DRESS syndrome (e.g., fever, rash, lymphadenopathy, eosinophilia, organ involvement)
  • Dizziness, vertigo, ataxia (vestibular effects)
  • Persistent or severe gastrointestinal upset (nausea, vomiting, diarrhea)
  • New or worsening skin discoloration (blue-gray pigmentation)

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 reversible inhibition of bone growth in the fetus.

Trimester-Specific Risks:

First Trimester: Potential for skeletal and dental effects, though less data than later trimesters.
Second Trimester: Significant risk of permanent tooth discoloration (yellow-gray-brown) and inhibition of bone growth.
Third Trimester: Significant 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.

Infant Risk: L3 (Moderate risk). Potential for tooth discoloration, inhibition of bone growth, and theoretical effects on gut flora. Monitor infant for diarrhea, candidiasis, and tooth staining. Consider alternative antibiotics or temporary interruption of breastfeeding.
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Pediatric Use

Minocycline is generally 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 and older should be carefully considered and only when other antibiotics are not appropriate or effective.

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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 has a higher lipophilicity compared to other tetracyclines, which contributes to its better tissue penetration, including the CNS, and longer half-life.
  • It is often preferred for acne due to its anti-inflammatory properties in addition to its antibacterial effects.
  • Vestibular side effects (dizziness, vertigo, ataxia) are more common with minocycline than with other tetracyclines, especially at higher doses or in women.
  • Minocycline can cause blue-gray skin, nail, and scleral discoloration with long-term use, which can be permanent.
  • Drug-induced lupus erythematosus and DRESS syndrome are rare but serious adverse effects that require immediate discontinuation.
  • While food interferes less with minocycline absorption than with other tetracyclines, it's still best to separate administration from dairy, antacids, and iron supplements.
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Alternative Therapies

  • Other tetracyclines (e.g., Doxycycline, Tetracycline)
  • Macrolides (e.g., Azithromycin, Erythromycin, Clarithromycin)
  • Lincosamides (e.g., Clindamycin)
  • For acne: Topical retinoids, topical antibiotics (e.g., clindamycin, erythromycin), benzoyl peroxide, oral contraceptives, isotretinoin (oral retinoid).
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Cost & Coverage

Average Cost: Varies widely, typically $30-$200+ per 30 capsules (75mg)
Generic Available: Yes
Insurance Coverage: Tier 1 or Tier 2 for generic, Tier 3 or higher for brand-name formulations. Coverage varies by insurance plan.
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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 your 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 happened.