Minocycline 100mg 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-acne agent
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Pharmacologic Class
Tetracycline antibiotic
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Pregnancy Category
Category D
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FDA Approved
Mar 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 pneumonia, urinary tract infections, and severe 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. 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. Consult your doctor or pharmacist for guidance on managing these interactions.
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 location, 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.
If it's close to the time for your next scheduled dose, skip the missed dose and resume your regular dosing schedule.
Do not take two doses at once 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 irritation of the esophagus.
  • Do not lie down for at least 30 minutes to 1 hour after taking the tablet to prevent esophageal irritation.
  • Avoid excessive sun exposure or artificial UV light (tanning beds) as minocycline can cause photosensitivity (severe sunburn). Use sunscreen and wear protective clothing.
  • Avoid taking antacids, iron supplements, or products containing calcium (like dairy) within 2-3 hours of taking minocycline, as they can reduce its absorption.
  • 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.
  • Complete the full course of medication as prescribed, even if symptoms improve, to prevent antibiotic resistance.

Dosing & Administration

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Adult Dosing

Standard Dose: Initial: 200 mg, then 100 mg every 12 hours; or 100 mg once daily for acne
Dose Range: 50 - 400 mg

Condition-Specific Dosing:

General Infections: 200 mg initial dose, then 100 mg every 12 hours
Acne Vulgaris (moderate to severe): 50 mg once daily or 100 mg once daily (extended-release formulations may differ)
Gonorrhea (uncomplicated): 200 mg initial dose, then 100 mg every 12 hours for 5 days
Syphilis: 200 mg initial dose, then 100 mg every 12 hours for 10-14 days
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Pediatric Dosing

Neonatal: Not established (generally contraindicated)
Infant: Not established (generally contraindicated)
Child: Generally not recommended for children < 8 years due to permanent tooth discoloration and bone growth inhibition. If used for severe infections in children â‰Ĩ 8 years: 4 mg/kg initial dose, then 2 mg/kg every 12 hours (max 200 mg/day)
Adolescent: Same as adult dosing for adolescents â‰Ĩ 8 years, considering weight and indication.
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Dose Adjustments

Renal Impairment:

Mild: No specific adjustment needed, but monitor for adverse effects.
Moderate: No specific adjustment needed, but monitor for adverse effects. Accumulation may occur.
Severe: Use with caution; consider reduced dosage or extended dosing interval if accumulation is a concern. Monitor for adverse effects.
Dialysis: Minocycline is not significantly removed by hemodialysis. No supplemental dose needed after dialysis, but use with caution due to potential for accumulation.

Hepatic Impairment:

Mild: Use with caution; monitor liver function.
Moderate: Use with caution; monitor liver function closely. Consider dose reduction.
Severe: Use with caution; monitor liver function closely. Consider dose reduction or alternative therapy.

Pharmacology

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Mechanism of Action

Minocycline is a tetracycline antibiotic that inhibits bacterial protein synthesis by binding reversibly to the 30S ribosomal subunit of susceptible bacteria. This prevents the binding of aminoacyl transfer RNA (tRNA) to the messenger RNA (mRNA)-ribosome complex, thereby interfering with bacterial growth and replication. It also exhibits anti-inflammatory properties, particularly relevant in acne treatment.
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Pharmacokinetics

Absorption:

Bioavailability: 90-100%
Tmax: 1-4 hours
FoodEffect: Food and dairy products do not significantly impair absorption, unlike other tetracyclines. However, taking with food may reduce gastrointestinal upset.

Distribution:

Vd: 1.5-2.5 L/kg
ProteinBinding: 70-75%
CnssPenetration: Yes (better than other tetracyclines, achieving therapeutic levels in CSF)

Elimination:

HalfLife: 11-22 hours (average 15 hours)
Clearance: Not readily available as a single rate, but primarily eliminated via non-renal routes.
ExcretionRoute: Primarily fecal (biliary excretion) and renal (glomerular filtration)
Unchanged: 10-30% (renal)
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Pharmacodynamics

OnsetOfAction: Variable, depends on infection type; antibacterial effects begin rapidly after therapeutic concentrations are reached.
PeakEffect: Peak plasma concentrations reached within 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

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
+ 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 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 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)
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 (reported with long-term use), which may cause:
+ 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 may affect body organs and can 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 side effects. However, if you notice any of the following symptoms, 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, 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:

  • Severe headache, blurred vision, or vision changes (signs of pseudotumor cerebri)
  • Dizziness, lightheadedness, or vertigo (especially common at the start of treatment)
  • Severe skin rash, blistering, or peeling (signs of severe skin reactions)
  • Yellowing of the skin or eyes, dark urine, pale stools (signs of liver problems)
  • Persistent nausea, vomiting, or diarrhea (especially if severe or bloody)
  • Unusual bleeding or bruising
  • Joint pain, swelling, or stiffness
  • Blue-gray discoloration of skin, nails, or gums (can occur with long-term use)
  • Signs of allergic reaction: swelling of face/lips/tongue, difficulty breathing, severe rash.
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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. Be sure to describe the allergic reaction and its symptoms.
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 (prescription, over-the-counter, natural products, and vitamins) and health conditions with your doctor and pharmacist. They will help determine if it is safe to take this medication with your other medications and health conditions. Never 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 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 lab 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, be cautious when exposed to sunlight, as it may cause you to sunburn more easily. If you experience increased sensitivity to the sun, inform your doctor.

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 will be irreversible. Discuss the potential risks with your doctor. Generally, this medication is not recommended for children under 8 years old, but there may be exceptions. Consult with your doctor to determine the best course of treatment.

Although less common, tooth discoloration has also been reported in adults. In these cases, the discoloration typically resolves after the medication is discontinued and a dental cleaning is performed. Consult with your doctor if you have concerns.

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 a condom.

If you are pregnant or become pregnant while taking this medication, it is crucial to 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 suspected overdose, seek immediate medical attention or call a poison control center. In the US, call 1-800-222-1222. Treatment is generally supportive, including gastric lavage if ingestion is recent.

Drug Interactions

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Contraindicated Interactions

  • Isotretinoin (increased risk of pseudotumor cerebri)
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Major Interactions

  • Anticoagulants (e.g., Warfarin): May potentiate anticoagulant effects, requiring dose adjustment of anticoagulant.
  • Penicillins: May interfere with the bactericidal action of penicillin; avoid concomitant use.
  • Oral Contraceptives: May reduce the effectiveness of oral contraceptives, leading to breakthrough bleeding or unintended pregnancy.
  • Ergot Alkaloids (e.g., Ergotamine, Dihydroergotamine): Increased risk of ergotism.
  • Methotrexate: May increase methotrexate toxicity.
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Moderate Interactions

  • Antacids (containing aluminum, calcium, magnesium): May decrease minocycline absorption; separate administration by at least 2-3 hours.
  • Iron Supplements: May decrease minocycline absorption; separate administration by at least 2-3 hours.
  • Bismuth Subsalicylate: May decrease minocycline absorption; separate administration.
  • Retinoids (oral, topical): Increased risk of pseudotumor cerebri (benign intracranial hypertension).
  • Digoxin: May increase digoxin absorption and serum levels.
  • Typhoid Vaccine (live, oral): Tetracyclines may inactivate the vaccine; avoid concurrent use.
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Minor Interactions

  • Not available (most interactions are moderate to major in clinical significance)

Monitoring

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Baseline Monitoring

Liver Function Tests (LFTs)

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

Timing: Prior to initiating therapy, particularly if prolonged use is anticipated or patient has history of liver disease.

Renal Function (BUN, Creatinine)

Rationale: To assess baseline renal function, especially in patients with pre-existing renal impairment or for prolonged therapy.

Timing: Prior to initiating therapy, particularly if prolonged use is anticipated or patient has history of renal disease.

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Routine Monitoring

Liver Function Tests (LFTs)

Frequency: Periodically, especially during prolonged therapy (e.g., >6 months) or if symptoms of hepatic dysfunction occur.

Target: Within normal limits

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

Renal Function (BUN, Creatinine)

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

Target: Within normal limits

Action Threshold: Significant elevation warrants dose adjustment or discontinuation.

Complete Blood Count (CBC)

Frequency: Periodically, especially during prolonged therapy, due to rare reports of hematologic abnormalities.

Target: Within normal limits

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

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Symptom Monitoring

  • Headache (especially severe or persistent)
  • Blurred vision or other visual disturbances
  • Dizziness or vertigo
  • Nausea, vomiting, diarrhea
  • Photosensitivity (severe sunburn-like reaction)
  • Skin rash or hives
  • Yellowing of skin or eyes (jaundice)
  • Dark urine or pale stools
  • Unusual fatigue or weakness
  • Joint pain or swelling
  • Blue-gray discoloration of skin, nails, or gums (with long-term use)

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 and inhibition of bone growth.
Third Trimester: Significant risk of permanent tooth discoloration and inhibition of bone growth.
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Lactation

Minocycline is excreted into breast milk. The American Academy of Pediatrics considers tetracyclines to be compatible with breastfeeding, but caution is advised. Potential risks to the infant include tooth discoloration, inhibition of bone growth, and candidiasis (thrush) due to alteration of gut flora. Use with caution and monitor the infant for adverse effects.

Infant Risk: L3 (Moderately Safe - potential for tooth staining, bone growth effects, and candidiasis in infant; generally considered compatible with monitoring).
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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. In children 8 years and older, it may be used for specific severe infections where benefits outweigh risks, with careful monitoring.

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Geriatric Use

No specific dose adjustment is typically required based on age alone. However, elderly patients may have reduced renal or hepatic function, which could lead to increased drug accumulation. Monitor renal and hepatic function, and observe for adverse effects such as dizziness or gastrointestinal upset.

Clinical Information

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Clinical Pearls

  • Minocycline is known for causing vestibular side effects (dizziness, vertigo, ataxia), especially with initial doses. Advise patients to be cautious when driving or operating machinery.
  • Long-term use of minocycline can lead to blue-gray skin, nail, and gum discoloration, which may be permanent.
  • Unlike other tetracyclines, minocycline absorption is not significantly affected by food or dairy products, but taking it with food may help reduce GI upset.
  • Patients should be advised about photosensitivity and to use sun protection.
  • Minocycline has a broader spectrum of activity than some other tetracyclines and is often used for acne due to its anti-inflammatory properties and ability to penetrate sebaceous glands.
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Alternative Therapies

  • Doxycycline (another tetracycline, often used for similar indications)
  • Tetracycline (older tetracycline, more GI side effects, food interactions)
  • Erythromycin (macrolide antibiotic, for susceptible infections)
  • Clindamycin (lincosamide antibiotic, for susceptible infections, including acne)
  • Azithromycin (macrolide antibiotic)
  • For acne: Topical retinoids, benzoyl peroxide, topical antibiotics (e.g., clindamycin, erythromycin), oral contraceptives (for females), isotretinoin (for severe recalcitrant acne).
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Cost & Coverage

Average Cost: $15 - $100+ per 30 tablets (generic 100mg)
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 is essential to contact your doctor promptly. To ensure safe and effective treatment, never share your medication with others or take someone else's medication. Some medications may come with an additional patient information leaflet, so it is a good idea to consult with your pharmacist. If you have any questions or concerns about this medication, do not hesitate to discuss them with 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 detailed information about the overdose, including the medication taken, the amount, and the time it occurred.