Minocycline 100mg Capsules

Manufacturer AUROBINDO 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
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 skin infections like acne, respiratory infections, and urinary tract infections. It works by stopping the growth of bacteria.
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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 place, avoiding the bathroom to prevent moisture exposure.
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 the missed dose is 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 esophageal irritation.
  • Avoid lying down for at least 30 minutes after taking the capsule.
  • Although minocycline's absorption is less affected by food/dairy than other tetracyclines, it's still generally advised to avoid taking it with dairy products, antacids, or iron supplements within 2-3 hours to ensure maximum absorption.
  • Avoid excessive sun exposure and use sunscreen (SPF 30 or higher) and protective clothing, as minocycline can make your skin more sensitive to sunlight (photosensitivity).
  • If you experience severe headache, blurred vision, or dizziness, contact your doctor immediately.
  • Do not use in children under 8 years of age due to risk of permanent tooth discoloration.

Dosing & Administration

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Adult Dosing

Standard Dose: Initial dose of 200 mg, followed by 100 mg every 12 hours. For acne, 50 mg once or twice daily.
Dose Range: 50 - 400 mg

Condition-Specific Dosing:

bacterialInfections: 200 mg initial, then 100 mg every 12 hours
acneVulgaris: 50 mg once or twice daily, or 100 mg once daily
gonorrhea: 200 mg initial, then 100 mg every 12 hours for 4 days
syphilis: 200 mg initial, then 100 mg every 12 hours for 10-15 days
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Pediatric Dosing

Neonatal: Not established (contraindicated in children under 8 years)
Infant: Not established (contraindicated in children under 8 years)
Child: Contraindicated in children under 8 years due to potential for permanent tooth discoloration and bone growth inhibition. For children 8 years and older: 4 mg/kg initial, then 2 mg/kg every 12 hours.
Adolescent: Same as adult dosing for children 8 years and older, typically 4 mg/kg initial, then 2 mg/kg every 12 hours, not to exceed adult dose.
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Dose Adjustments

Renal Impairment:

Mild: No specific adjustment generally required, but monitor for adverse effects.
Moderate: No specific adjustment generally required, but monitor for adverse effects. Consider lower doses or extended intervals if severe impairment.
Severe: Use with caution. Consider lower doses (e.g., 100 mg every 24 hours) or extended intervals. Monitor for signs of toxicity (e.g., azotemia, hyperphosphatemia).
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. Monitor liver function.
Moderate: Use with caution. Consider dose reduction and monitor liver function closely.
Severe: Use with extreme caution. Significant dose reduction may be necessary. Monitor liver function and drug levels 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 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 generally recommended to avoid taking with dairy products, antacids, or iron preparations within 2-3 hours to maximize absorption.

Distribution:

Vd: 1.3 L/kg
ProteinBinding: 70-75%
CnssPenetration: Yes (achieves therapeutic concentrations in CSF, tears, and saliva)

Elimination:

HalfLife: 11-22 hours (longer in renal impairment)
Clearance: Not available
ExcretionRoute: Fecal (major route), renal (minor route, approximately 10-30% unchanged)
Unchanged: 10-30%
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Pharmacodynamics

OnsetOfAction: Variable, depends on infection type; generally within hours to days for clinical effect.
PeakEffect: Not available (related to peak plasma concentrations)
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 Attention Immediately

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 help right away:

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.
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 irritation.
Genital irritation.
Vaginal itching or discharge.

Important Warnings

Diarrhea is a common side effect of antibiotics. However, a severe form called C. diff-associated diarrhea (CDAD) can occur, which may lead to a life-threatening bowel problem. If you experience stomach pain, cramps, or loose, watery, or bloody stools, contact your doctor immediately.
Liver problems, including fatal cases, have been reported with this medication. If you notice signs of liver problems, such as dark urine, tiredness, decreased appetite, upset stomach or stomach pain, light-colored stools, vomiting, or yellow skin or eyes, seek medical attention right away.
Raised pressure in the brain has been reported, which may lead to loss of eyesight. If you experience headaches or eyesight problems, such as blurred vision, double vision, or loss of eyesight, contact your doctor immediately.
Cases of thyroid cancer have been reported with long-term use of this medication. If you notice lasting hoarseness, a neck mass, or trouble breathing or swallowing, seek medical attention right away.
Severe skin reactions, including Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN), and other serious reactions, can occur. If you experience signs like 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, seek medical help immediately.

Other Side Effects

Not all side effects are severe. However, if you experience 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.

Reporting Side Effects

If you have questions about side effects or want to report any side effects, contact your doctor or the FDA at 1-800-332-1088. You can also report side effects 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 increased intracranial pressure)
  • Severe dizziness or vertigo
  • Severe skin rash, blistering, peeling, or swelling (signs of severe skin reactions like SJS, TEN, DRESS)
  • Yellowing of the skin or eyes, dark urine, severe stomach pain (signs of liver problems)
  • Unusual bleeding or bruising, persistent sore throat, fever, or fatigue (signs of blood disorders)
  • Joint pain, swelling, or stiffness (signs of drug-induced lupus-like syndrome)
  • Blue-gray skin discoloration (especially with long-term use)
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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 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. They will help determine if it is safe to take this medication with your existing treatments 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 your full attention, 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 you have with your doctor. Additionally, 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. Furthermore, this medication can increase your susceptibility to sunburn. Exercise caution when spending time in the sun, and promptly inform your doctor if you experience unusual sunburn.

Generally, this medication is not recommended for children under 8 years old. However, in some cases, it may be necessary for younger children to take this drug. If this is the case, 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 discoloration will not resolve. It is essential to discuss this potential side effect with your doctor. Although less common, tooth discoloration has also been reported in adults, but it typically resolves after the medication is discontinued and a dental cleaning is performed.

When taking this medication, it is crucial to note that 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 a condom.

If you are pregnant or become pregnant while taking this medication, it is vital to contact your doctor immediately, as this drug may pose a risk to the unborn baby.
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Overdose Information

Overdose Symptoms:

  • Nausea
  • Vomiting
  • Diarrhea
  • Dizziness
  • Lightheadedness
  • Increased intracranial pressure (headache, blurred vision)

What to Do:

Call 1-800-222-1222 (Poison Control Center) immediately. Treatment is primarily supportive. Gastric lavage may be indicated if ingestion is recent. Hemodialysis is not effective in removing minocycline.

Drug Interactions

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Contraindicated Interactions

  • Isotretinoin and other oral retinoids (increased risk of pseudotumor cerebri)
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Major Interactions

  • Anticoagulants (e.g., Warfarin - may potentiate anticoagulant effect, monitor INR)
  • Penicillins (tetracyclines may interfere with the bactericidal action of penicillins, avoid concomitant use)
  • Ergot alkaloids (theoretical risk of ergotism, though less documented for minocycline)
  • Methoxyflurane (may result in fatal renal toxicity)
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Moderate Interactions

  • Antacids containing aluminum, calcium, or magnesium (may decrease minocycline absorption, separate by 2-3 hours)
  • Iron preparations (may decrease minocycline absorption, separate by 2-3 hours)
  • Bismuth subsalicylate (may decrease minocycline absorption)
  • Oral contraceptives (may decrease efficacy of oral contraceptives, advise backup method)
  • Typhoid vaccine, live (antibiotics may reduce therapeutic effect of live bacterial vaccines, administer minocycline at least 24 hours after vaccine)
  • Cholestyramine, colestipol (may decrease minocycline absorption)
  • Barbiturates, Carbamazepine, Phenytoin (may decrease minocycline half-life)
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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 initiating therapy, especially for long-term use or in patients with pre-existing liver disease.

Renal function (BUN, creatinine)

Rationale: To establish baseline and identify pre-existing renal impairment, though minocycline is less renally cleared than other tetracyclines, caution is still warranted.

Timing: Prior to initiating therapy, especially for long-term use or in patients with pre-existing renal disease.

Complete Blood Count (CBC) with differential

Rationale: To establish baseline and monitor for potential hematologic abnormalities (e.g., neutropenia, thrombocytopenia, hemolytic anemia) with long-term use.

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

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Routine Monitoring

Liver function tests (ALT, AST, bilirubin)

Frequency: Periodically, especially with long-term therapy (e.g., every 3-6 months) or if symptoms of hepatotoxicity develop.

Target: Within normal limits

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

Renal function (BUN, creatinine)

Frequency: Periodically, especially with long-term 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) with differential

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

Target: Within normal limits

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

Intracranial pressure (symptom monitoring)

Frequency: Ongoing throughout therapy.

Target: Not applicable

Action Threshold: Development of severe headache, blurred vision, diplopia, or papilledema requires immediate medical attention and discontinuation.

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Symptom Monitoring

  • Dizziness/vertigo (especially at initiation or with higher doses)
  • Photosensitivity (severe sunburn-like reaction)
  • Gastrointestinal upset (nausea, vomiting, diarrhea)
  • Skin discoloration (blue-gray pigmentation, especially in sun-exposed areas or scars, with long-term use)
  • Tooth discoloration (permanent in developing teeth of children under 8)
  • Headache, blurred vision, diplopia, papilledema (signs of pseudotumor cerebri/idiopathic intracranial hypertension)
  • Rash, fever, lymphadenopathy, eosinophilia (signs of Drug Reaction with Eosinophilia and Systemic Symptoms - DRESS syndrome)
  • Joint pain, swelling (drug-induced lupus-like syndrome)
  • Sore throat, fever, fatigue (signs of blood dyscrasias)

Special Patient Groups

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Pregnancy

Minocycline is contraindicated in pregnancy (Pregnancy Category D). It 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 teratogenic effects, though primarily known for effects on calcified tissues.
Second Trimester: High risk of permanent tooth discoloration and inhibition of bone growth in the developing fetus.
Third Trimester: High risk of permanent tooth discoloration and inhibition of bone growth in the developing 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 permanent tooth discoloration, inhibition of bone growth, and theoretical risk of effects on gut flora. Monitor infant 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 children 8 years and older should be carefully considered 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 may have age-related decreases in renal or hepatic function, which may necessitate dose adjustments or closer monitoring. Elderly patients may also be more susceptible to adverse effects like dizziness or pseudotumor cerebri.

Clinical Information

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Clinical Pearls

  • Minocycline is unique among tetracyclines for its higher lipophilicity, leading to better tissue penetration (e.g., CNS, skin) and a longer half-life.
  • Unlike other tetracyclines, minocycline's absorption is less affected by food or dairy products, but it's still prudent to separate administration from antacids, iron, and calcium supplements by 2-3 hours.
  • A common and often dose-related side effect is dizziness/vertigo, especially at the initiation of therapy or with higher doses. Advise patients about this and caution against driving or operating machinery.
  • Minocycline can cause blue-gray skin, nail, and tooth discoloration with long-term use, which can be permanent.
  • Patients should be strongly advised about photosensitivity and to use sun protection.
  • Be vigilant for signs of pseudotumor cerebri (idiopathic intracranial hypertension), such as severe headache, blurred vision, or papilledema, especially if co-administered with retinoids.
  • Minocycline has anti-inflammatory properties in addition to its antibiotic effects, making it particularly useful for acne vulgaris at lower doses.
  • Take with a full glass of water and remain upright for at least 30 minutes to prevent esophageal irritation/ulceration.
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Alternative Therapies

  • Doxycycline (another tetracycline, often used for similar indications)
  • Tetracycline (older tetracycline, more food/dairy interactions)
  • Erythromycin (macrolide, for acne or certain infections)
  • Clindamycin (lincosamide, for acne or anaerobic infections)
  • Trimethoprim/sulfamethoxazole (for skin infections, UTIs)
  • Oral contraceptives (for hormonal acne)
  • Topical retinoids (for acne)
  • Benzoyl peroxide (for acne)
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Cost & Coverage

Average Cost: Varies widely, typically $10-$100 per 30 capsules (100mg)
Generic Available: Yes
Insurance Coverage: Tier 1 or Tier 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 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, including the amount taken and the time it happened, to ensure you receive the best possible care.