Minocycline 75mg Capsules

Manufacturer CARACO 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; Protein synthesis inhibitor
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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 acne, pneumonia, and certain sexually transmitted 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. If it causes stomach upset, take it with food to help minimize this side effect.
However, do not take your medication at the same time as products containing iron or antacids that have aluminum, calcium, or magnesium. Consult with your doctor or pharmacist for guidance on how to manage 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.
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 esophageal irritation. Remain upright for at least 30 minutes after taking.
  • Avoid taking with antacids, iron supplements, or dairy products. If necessary, separate doses by at least 2-4 hours.
  • Avoid excessive sun exposure and use sunscreen and protective clothing, as minocycline can cause severe sunburn (photosensitivity).
  • This medication may cause dizziness or lightheadedness, especially when starting. Be careful when driving or operating machinery.
  • If you are taking oral contraceptives, consider using an alternative form of birth control while on minocycline, 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: For most infections: 200 mg initially, then 100 mg every 12 hours OR 100 mg initially, then 50 mg every 6 hours. For acne: 50-100 mg once or twice daily.
Dose Range: 50 - 400 mg

Condition-Specific Dosing:

Acne vulgaris: 50 mg once or twice daily, or 100 mg once daily
Bacterial infections (general): 200 mg initially, then 100 mg every 12 hours
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
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Pediatric Dosing

Neonatal: Not established (contraindicated in children < 8 years)
Infant: Not established (contraindicated in children < 8 years)
Child: Contraindicated in children under 8 years of age due to potential for permanent tooth discoloration and bone growth inhibition. For children â‰Ĩ 8 years: 4 mg/kg initially, then 2 mg/kg every 12 hours (max 200 mg/day).
Adolescent: Same as adult dosing for children â‰Ĩ 8 years, typically 50-100 mg once or twice daily for acne, or 200 mg initially then 100 mg every 12 hours for infections.
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Dose Adjustments

Renal Impairment:

Mild: No specific adjustment generally needed, but monitor for increased side effects.
Moderate: No specific adjustment generally needed, but monitor for increased side effects.
Severe: Use with caution; consider lower doses or extended intervals if accumulation occurs. Minocycline is less dependent on renal excretion than other tetracyclines.
Dialysis: Not significantly removed by hemodialysis or peritoneal dialysis. No supplemental dose needed after dialysis, but monitor for adverse effects.

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 or avoid; significant dose reduction may be necessary, 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 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: Food, milk, and some dairy products may decrease absorption, but to a lesser extent than other tetracyclines. It is generally recommended to take minocycline with a full glass of water, and without food if possible, or at least 1-2 hours before or 4 hours after antacids or iron preparations.

Distribution:

Vd: 1.3 L/kg
ProteinBinding: 70-75%
CnssPenetration: Yes (good penetration, leading to vestibular side effects)

Elimination:

HalfLife: 11-22 hours (longer than other tetracyclines)
Clearance: Not available
ExcretionRoute: Primarily fecal (biliary excretion), with some renal excretion (5-10% unchanged drug)
Unchanged: 5-10%
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Pharmacodynamics

OnsetOfAction: Rapid (therapeutic concentrations achieved within hours)
PeakEffect: Within 1-4 hours of administration
DurationOfAction: Sustained therapeutic levels due to long half-life, allowing 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
+ 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 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, 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
+ Eyesight problems (blurred vision, double vision, or loss of vision)
Thyroid cancer (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 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; or 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:

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 about side effects, contact your doctor. You can also report side effects to the FDA at 1-800-332-1088 or https://www.fda.gov/medwatch.
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Seek Immediate Medical Attention If You Experience:

  • Severe headache, especially with blurred vision or double vision (signs of increased pressure in the brain)
  • Yellowing of the skin or eyes (jaundice), dark urine, or severe stomach pain (signs of liver problems)
  • Severe skin rash, blistering, or peeling (signs of a severe allergic reaction)
  • Unusual bleeding or bruising
  • Persistent diarrhea, especially if it contains blood or mucus (may be a sign of a serious bowel infection)
  • Joint pain, muscle aches, or fever (may be signs of 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 allergic reaction you experienced, including any symptoms that occurred.
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 disclose all your medications, including prescription and over-the-counter (OTC) drugs, natural products, and vitamins, as well as any existing health problems. Your doctor and pharmacist need this information to ensure safe use and potential interactions with this medication.

Do not initiate, discontinue, or modify the dosage of any medication without first consulting your doctor to confirm it is safe to do so in conjunction with this medication.
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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, to monitor your condition. Be sure to discuss any concerns or questions with your doctor.

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.

You may be more susceptible to sunburn while taking this medication, so exercise caution when exposed to the sun. If you experience unusual sunburn, inform your doctor promptly.

Generally, this medication is not recommended for children under 8 years old. However, in some cases, your doctor may prescribe it for younger children. It is essential to discuss the potential risks and benefits with your doctor. One potential risk is a permanent change in tooth color to a yellow-gray-brown hue, which has been observed in children under 8 years old. Although this change is irreversible, it is essential to consult with your doctor if you have concerns.

In rare cases, adults may also experience a change in tooth color, but this typically reverses after stopping the medication and undergoing dental cleaning. Your doctor can provide more information on this potential side effect.

If you are using birth control pills or other hormone-based contraception, please note that this medication may reduce their effectiveness. To prevent pregnancy, consider using an additional form of birth control, such as condoms, while taking this drug.

It is vital to avoid taking this medication during pregnancy, as it may harm the unborn baby. If you become pregnant or suspect you may be pregnant while taking this medication, contact your doctor immediately.
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Overdose Information

Overdose Symptoms:

  • Nausea
  • Vomiting
  • Diarrhea
  • Dizziness
  • Lightheadedness
  • Increased intracranial pressure (headache, visual disturbances)

What to Do:

Seek immediate medical attention or call a poison control center. In the US, call 1-800-222-1222.

Drug Interactions

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Major Interactions

  • Isotretinoin and other retinoids (increased risk of pseudotumor cerebri/intracranial hypertension)
  • Oral anticoagulants (e.g., warfarin) - may potentiate anticoagulant effect
  • Penicillins (tetracyclines may interfere with the bactericidal action of penicillins)
  • Ergot alkaloids (theoretical risk of ergotism, though less documented for minocycline)
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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 (may decrease efficacy of oral contraceptives, leading to breakthrough bleeding or pregnancy)
  • Methotrexate (may increase methotrexate toxicity)
  • Live bacterial vaccines (e.g., typhoid vaccine) - may reduce vaccine efficacy
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Minor Interactions

  • Digoxin (may increase digoxin levels in some patients due to altered gut flora)

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 is metabolized in the liver and can cause hepatotoxicity.

Timing: Prior to initiation, especially for long-term therapy or in patients with liver disease.

Renal function (BUN, creatinine)

Rationale: To establish baseline, although minocycline is less renally excreted than other tetracyclines, monitoring is prudent in patients with renal impairment.

Timing: Prior to initiation, especially in patients with known renal dysfunction.

Complete Blood Count (CBC)

Rationale: To establish baseline, as tetracyclines can rarely cause hematologic abnormalities (e.g., neutropenia, thrombocytopenia).

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

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Routine Monitoring

Liver function tests (ALT, AST, bilirubin)

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.

Renal function (BUN, creatinine)

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

Target: Within normal limits

Action Threshold: Significant elevation warrants dose adjustment or discontinuation.

Signs/symptoms of intracranial hypertension (pseudotumor cerebri)

Frequency: Ongoing throughout therapy

Target: Absence of symptoms

Action Threshold: Headache, blurred vision, diplopia, papilledema warrant immediate discontinuation and ophthalmologic evaluation.

Skin examination for photosensitivity

Frequency: Ongoing throughout therapy

Target: Absence of severe sunburn-like reactions

Action Threshold: Severe photosensitivity warrants discontinuation.

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Symptom Monitoring

  • Dizziness
  • Vertigo
  • Ataxia
  • Nausea
  • Vomiting
  • Diarrhea
  • Photosensitivity (severe sunburn-like reaction)
  • Headache (especially severe or persistent)
  • Blurred vision or other visual disturbances
  • Yellowing of skin or eyes (jaundice)
  • Darkening of skin, nails, or teeth (hyperpigmentation)
  • Severe rash or blistering (e.g., Stevens-Johnson syndrome)
  • Joint pain or swelling (drug-induced lupus-like syndrome)

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 abnormalities and tooth bud effects, though less studied 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, especially during the latter half of pregnancy.
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Lactation

Minocycline is excreted into breast milk. While the amount is generally low, there is a theoretical risk of tooth discoloration and inhibition of bone growth in the nursing infant. The American Academy of Pediatrics considers tetracyclines to be compatible with breastfeeding with caution. Weigh the benefits of breastfeeding against the potential risks to the infant.

Infant Risk: Low to moderate risk of tooth discoloration and bone growth inhibition. Monitor infant for diarrhea, candidiasis, and tooth staining.
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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 older children (â‰Ĩ 8 years) should be carefully considered and only when other antibiotics are not suitable.

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Geriatric Use

Generally well-tolerated in elderly patients. However, elderly patients may be more susceptible to adverse effects such as dizziness and lightheadedness. Monitor renal and hepatic function, as these may be impaired in older adults.

Clinical Information

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Clinical Pearls

  • Minocycline has a higher incidence of vestibular side effects (dizziness, vertigo, ataxia) compared to other tetracyclines, especially at higher doses. These effects are often dose-related and more common in females.
  • Unlike other tetracyclines, minocycline is primarily eliminated via biliary/fecal excretion, making it a potential option for patients with renal impairment, though caution is still advised.
  • Minocycline can cause blue-gray skin, nail, and tooth discoloration with long-term use, which can be permanent.
  • Patients should be advised to take minocycline with a full glass of water and remain upright for at least 30 minutes to minimize the risk of esophageal irritation and ulceration.
  • Photosensitivity is a common side effect; advise patients to use sun protection.
  • Minocycline has anti-inflammatory properties in addition to its antibiotic effects, making it particularly useful for acne vulgaris and rosacea.
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Alternative Therapies

  • Doxycycline (another tetracycline, often used for similar indications)
  • Tetracycline (older tetracycline, less commonly used)
  • Erythromycin (for acne, certain infections)
  • Azithromycin (for certain infections)
  • Clindamycin (for acne, certain infections)
  • Oral retinoids (e.g., isotretinoin for severe acne, but contraindicated with minocycline)
  • Topical antibiotics (e.g., clindamycin, erythromycin, dapsone for acne)
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Cost & Coverage

Average Cost: Varies widely, typically $30-$150 per 30 capsules (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 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.