Minocycline 75mg Tablets

Manufacturer TORRENT Active Ingredient Minocycline Tablets(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, Anti-inflammatory
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Pharmacologic Class
Tetracycline antibiotic
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Pregnancy Category
D
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FDA Approved
Jan 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 acne. It works by stopping the growth of bacteria. For acne, it also has anti-inflammatory effects.
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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 with your prescription 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.
Establish a routine by taking your medication at the same time every day.
You can take your medication with or without food. If it causes stomach upset, consider taking it with food.
However, do not take your medication at the same time as products containing iron or antacids that have aluminum, calcium, or magnesium. Consult your doctor or pharmacist for guidance.
Stay hydrated by drinking plenty of non-caffeinated fluids, 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.
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.
If it's close to the time for your next dose, skip the missed dose and resume your regular schedule.
Do not take two doses at the same time or take extra doses to make up for a missed dose.
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Lifestyle & Tips

  • Take with a full glass of water to prevent esophageal irritation. Do not lie down for at least 30 minutes (preferably 1 hour) after taking.
  • Avoid taking antacids, iron supplements, or products containing calcium (like dairy products) within 2-3 hours before or after taking minocycline, as they can reduce its absorption.
  • Protect yourself from the sun and artificial UV light (tanning beds) while taking this medication, as it can make your skin more sensitive to light (photosensitivity). Use sunscreen and wear protective clothing.
  • If you are taking oral contraceptives, use an additional non-hormonal birth control method (like condoms) while taking minocycline and for at least 7 days after, as minocycline may reduce the effectiveness of birth control pills.
  • Do not skip doses or stop taking the medication early, even if you feel better, unless directed by your doctor. This can lead to antibiotic resistance.

Dosing & Administration

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Adult Dosing

Standard Dose: For acne: 50 mg once or twice daily; For infections: 200 mg initially, then 100 mg every 12 hours or 50 mg every 6 hours.
Dose Range: 50 - 400 mg

Condition-Specific Dosing:

Acne vulgaris: 50 mg once or twice daily, or 75 mg once daily (extended-release)
Bacterial infections (general): 200 mg initially, then 100 mg every 12 hours or 50 mg every 6 hours
Gonorrhea (uncomplicated): 100 mg every 12 hours for 5 days
Syphilis: 100 mg every 12 hours for 10-14 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 and older: 4 mg/kg initially, then 2 mg/kg every 12 hours (max 200 mg/day).
Adolescent: Same as adult dosing for children 8 years and older, considering weight and severity of infection.
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Dose Adjustments

Renal Impairment:

Mild: No dosage adjustment typically required.
Moderate: No dosage adjustment typically required, but monitor for adverse effects.
Severe: Use with caution. Dosage reduction may be considered (e.g., 200 mg initially, then 50 mg every 12-24 hours) if accumulation occurs, though minocycline is less dependent on renal excretion than other tetracyclines.
Dialysis: Minocycline is not significantly removed by hemodialysis. No supplemental dose needed after dialysis, but monitor for adverse effects.

Hepatic Impairment:

Mild: No specific adjustment, but use with caution.
Moderate: Use with caution. Monitor for signs of hepatotoxicity.
Severe: Use with caution. Dosage reduction may be considered, and 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 amino acids to the growing peptide chain, leading to bacteriostasis. It also exhibits anti-inflammatory properties, particularly useful in conditions like acne and rosacea, by inhibiting lipase activity, reducing reactive oxygen species, and modulating cytokine production.
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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's still recommended to avoid taking with antacids containing aluminum, calcium, or magnesium, or iron preparations.

Distribution:

Vd: 1.3 L/kg
ProteinBinding: 70-75%
CnssPenetration: Yes (good penetration into CSF, tears, saliva, and sputum)

Elimination:

HalfLife: 11-22 hours (prolonged in renal impairment)
Clearance: Not available
ExcretionRoute: Renal (10-30%), fecal (30-50%)
Unchanged: Not available
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Pharmacodynamics

OnsetOfAction: Within hours (antibacterial effect)
PeakEffect: Within 1-4 hours (plasma concentration)
DurationOfAction: 12-24 hours (due to long half-life)

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, 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 problems), 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 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 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), especially if severe or accompanied by:
+ Stomach pain
+ Cramps
+ Loose, watery, or bloody stools
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 (rarely reported with long-term use), which may cause:
+ Lasting hoarseness
+ Neck mass
+ Trouble breathing or swallowing
Severe skin reactions, such as:
+ Stevens-Johnson syndrome (SJS)
+ Toxic epidermal necrolysis (TEN)
+ Other serious reactions, which may affect body organs and be life-threatening
+ Signs 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

Most people do not experience side effects or only have mild ones. However, if you notice any of the following, contact your doctor or seek medical attention if they bother you or do not go away:

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

This is not an exhaustive list of possible side effects. If you have questions or concerns, 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 with blurred vision, dizziness, or nausea (could be signs of increased pressure in the brain, pseudotumor cerebri).
  • Severe or watery diarrhea, especially if it occurs weeks after stopping the medication (could be C. difficile infection).
  • Unusual skin discoloration (blue-gray patches, especially in sun-exposed areas, scars, or gums).
  • Severe skin rash, blistering, or peeling (could be a severe skin reaction).
  • Yellowing of the skin or eyes, dark urine, or persistent nausea/vomiting (signs of liver problems).
  • Unusual bleeding or bruising, fever, sore throat (signs of blood problems).
  • Joint pain, muscle aches, or swelling (could be a 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 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 other 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.

Regular blood tests will be necessary, as directed by your doctor. Be sure to discuss any concerns or questions with your doctor. Additionally, this medication may interfere with certain laboratory tests, so it is crucial to notify all 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 promptly.

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. Discuss the potential risks with your doctor, as this medication is generally not recommended for children under 8 years old, except in specific circumstances.

Although less common, tooth discoloration has also been reported in adults, which typically resolves after discontinuing the medication and undergoing dental cleaning. Consult your doctor if you have concerns about tooth discoloration.

When taking this medication, birth control pills and other hormone-based contraceptives may be less effective. To prevent pregnancy, consider using 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 pose a risk to 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 a poison control center (1-800-222-1222). Treatment is generally supportive, including gastric lavage if appropriate, and symptomatic management.

Drug Interactions

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Contraindicated Interactions

  • Isotretinoin (increased risk of pseudotumor cerebri)
  • Acitretin (increased risk of pseudotumor cerebri)
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Major Interactions

  • Anticoagulants (e.g., Warfarin - increased INR/bleeding risk)
  • Penicillins (tetracyclines can interfere with bactericidal action of penicillins)
  • Ergot alkaloids (potential for ergotism, though less documented for minocycline)
  • Methoxyflurane (potential for fatal renal toxicity)
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Moderate Interactions

  • Oral contraceptives (decreased efficacy of oral contraceptives, leading to breakthrough bleeding or pregnancy)
  • Antacids (containing aluminum, calcium, magnesium - decreased minocycline absorption)
  • Iron preparations (decreased minocycline absorption)
  • Bismuth subsalicylate (decreased minocycline absorption)
  • Cholestyramine (decreased minocycline absorption)
  • Barbiturates (decreased minocycline half-life)
  • Carbamazepine (decreased minocycline half-life)
  • Phenytoin (decreased minocycline half-life)
  • Digoxin (increased digoxin levels in some patients)
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Minor Interactions

  • Food (minimal effect on absorption, but avoid dairy/antacids/iron within 2-3 hours)

Monitoring

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Baseline Monitoring

Liver function tests (ALT, AST, bilirubin)

Rationale: To establish baseline and identify pre-existing hepatic impairment, especially for long-term therapy.

Timing: Prior to initiating therapy, particularly for prolonged use.

Renal function tests (BUN, creatinine)

Rationale: To establish baseline and identify pre-existing renal impairment.

Timing: Prior to initiating therapy, particularly for prolonged use.

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Routine Monitoring

Liver function tests (ALT, AST, bilirubin)

Frequency: Periodically (e.g., every 3-6 months) for long-term therapy (e.g., acne).

Target: Within normal limits.

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

Renal function tests (BUN, creatinine)

Frequency: Periodically for long-term therapy or in patients with pre-existing renal impairment.

Target: Within normal limits.

Action Threshold: Significant elevation warrants dosage adjustment or discontinuation.

Complete Blood Count (CBC)

Frequency: Periodically for long-term therapy.

Target: Within normal limits.

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

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Symptom Monitoring

  • Photosensitivity (sunburn-like reaction)
  • Dizziness, vertigo, lightheadedness (vestibular side effects)
  • Gastrointestinal upset (nausea, vomiting, diarrhea)
  • Headache, blurred vision, papilledema (signs of pseudotumor cerebri)
  • Skin discoloration (blue-gray pigmentation, especially in sun-exposed areas or scars)
  • Tooth discoloration (permanent, especially in children under 8)
  • Joint pain, swelling (drug-induced lupus-like syndrome)
  • Severe or persistent diarrhea (Clostridioides difficile-associated diarrhea)
  • Signs of allergic reaction (rash, itching, swelling, difficulty breathing)

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 less data specifically for first trimester.
Second Trimester: Significant risk of permanent tooth discoloration (enamel hypoplasia) and inhibition of bone growth.
Third Trimester: Significant risk of permanent tooth discoloration (enamel hypoplasia) and inhibition of bone growth.
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Lactation

Minocycline is excreted into breast milk. Due to the potential for serious adverse effects in the nursing infant, including tooth discoloration and inhibition of bone growth, minocycline is generally not recommended during breastfeeding. 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 disruption of gut flora in the infant. Monitor for diarrhea, candidiasis, and tooth staining.
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Pediatric Use

Minocycline is 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 older children should be carefully considered and only when other antibiotics are not suitable.

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Geriatric Use

No specific dosage adjustment is generally required for elderly patients based on age alone. However, elderly patients are more likely to have decreased renal or hepatic function, which may necessitate careful monitoring and potential dosage adjustment. They may also be more susceptible to vestibular side effects (dizziness, vertigo).

Clinical Information

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Clinical Pearls

  • Minocycline has a higher lipophilicity compared to other tetracyclines, leading to better tissue penetration, including the CNS.
  • It is less likely to cause photosensitivity than doxycycline, but sun protection is still advised.
  • Vestibular side effects (dizziness, vertigo, ataxia) are more common with minocycline than with other tetracyclines, especially at higher doses or in women.
  • Long-term use, particularly for acne, can lead to skin, nail, and tooth discoloration (blue-gray pigmentation), which can be permanent.
  • Minocycline has anti-inflammatory properties independent of its antimicrobial activity, making it effective for inflammatory conditions like acne and rosacea.
  • Unlike other tetracyclines, minocycline absorption is not significantly impaired by food or dairy products, but it's still best to separate from antacids and iron supplements.
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Alternative Therapies

  • Doxycycline (another tetracycline, often used for similar indications)
  • Tetracycline (older tetracycline)
  • Erythromycin (macrolide antibiotic)
  • Clindamycin (lincosamide antibiotic)
  • Azithromycin (macrolide antibiotic)
  • Topical retinoids (for acne)
  • Benzoyl peroxide (for acne)
  • Oral contraceptives (for hormonal acne)
  • Isotretinoin (for severe acne)
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Cost & Coverage

Average Cost: $10 - $50 per 30 tablets (generic 75mg)
Generic Available: Yes
Insurance Coverage: Tier 1 or Tier 2 (for 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, including the amount taken and the time it happened, to facilitate prompt and effective treatment.