Minocycline 50mg Capsules

Manufacturer TORRENT 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 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 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.
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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 (preferably 1 hour) after taking.
  • Avoid excessive sun exposure and use sunscreen and protective clothing, as minocycline can make your skin more sensitive to sunlight (photosensitivity).
  • Do not take antacids, iron supplements, or products containing calcium (like milk or dairy products) within 2-3 hours before or 4-6 hours after taking minocycline, as they can reduce its absorption.
  • If you are taking oral contraceptives, use an additional non-hormonal birth control method (like condoms) while on minocycline and for at least 7 days after, as minocycline may reduce the effectiveness of birth control pills.
  • Complete the full course of medication as prescribed, even if you start feeling better, to prevent the infection from returning and to reduce the risk of antibiotic resistance.

Dosing & Administration

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Adult Dosing

Standard Dose: 100 mg initially, then 50 mg every 12 hours or 100 mg once daily
Dose Range: 50 - 200 mg

Condition-Specific Dosing:

Acne vulgaris: 50 mg once daily or 50 mg twice daily
Bacterial infections (general): 200 mg initially, then 100 mg every 12 hours or 100 mg once daily for mild-moderate infections
Gonorrhea: 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 due to tooth discoloration and bone development effects)
Infant: Not established (contraindicated due to tooth discoloration and bone development effects)
Child: Not recommended for children under 8 years of age due to permanent tooth discoloration and bone development effects. For children â‰Ĩ8 years: 4 mg/kg initially, then 2 mg/kg every 12 hours (max 200 mg/day).
Adolescent: Same as adult dosing for adolescents â‰Ĩ8 years of age, typically 50 mg once daily or 50 mg twice daily for acne, or 100 mg once daily for other infections.
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Dose Adjustments

Renal Impairment:

Mild: No dosage adjustment typically needed, but monitor for adverse effects.
Moderate: No dosage adjustment typically needed, but monitor for adverse effects. Use with caution.
Severe: Use with caution; dosage reduction may be necessary in severe impairment (CrCl <10 mL/min) or if accumulation occurs. Monitor drug levels if possible.
Dialysis: Minocycline is not significantly removed by hemodialysis. No supplemental dose needed after dialysis, but use with caution and monitor for adverse effects.

Hepatic Impairment:

Mild: No specific dosage adjustment recommended, but use with caution.
Moderate: Use with caution; monitor for signs of hepatotoxicity. Dosage reduction may be considered.
Severe: Use with extreme caution; dosage reduction may be necessary. 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 binding of aminoacyl-tRNA to the mRNA-ribosome complex. 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: Absorption is not significantly affected by food or dairy products, unlike other tetracyclines, but it's recommended to take with a full glass of water to prevent esophageal irritation.

Distribution:

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

Elimination:

HalfLife: 11-22 hours (prolonged in renal impairment)
Clearance: Not available (variable)
ExcretionRoute: Primarily fecal (biliary excretion), with a smaller portion excreted renally.
Unchanged: 5-10% (renal)
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Pharmacodynamics

OnsetOfAction: Rapid (within hours for antibacterial effect)
PeakEffect: Within 1-4 hours (plasma concentration)
DurationOfAction: Sustained 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 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, such as:
+ 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
+ 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 to a darker shade
Mouth irritation or mouth sores
Burning, numbness, or tingling sensations
Redness or white patches in the mouth or throat
Rectal irritation
Genital irritation
Vaginal itching or discharge

Antibiotic-Related Side Effects

Diarrhea is a common side effect of antibiotics. However, a severe form called C. diff-associated diarrhea (CDAD) may occur, which can lead to a life-threatening bowel problem. If you experience:

Stomach pain
Cramps
Loose, watery, or bloody stools

Contact your doctor immediately. Do not treat diarrhea without consulting your doctor.

Other Serious Side Effects

Liver problems: Call your doctor right away if you notice:
+ Dark urine
+ Fatigue
+ Decreased appetite
+ Upset stomach or stomach pain
+ Light-colored stools
+ Vomiting
+ Yellow skin or eyes
Raised pressure in the brain: Contact your doctor immediately if you experience:
+ Headache
+ Eyesight problems, such as blurred vision, double vision, or loss of vision
Thyroid cancer: Report any of the following symptoms to your doctor:
+ Lasting hoarseness
+ Neck mass
+ Trouble breathing or swallowing
Severe skin reactions, including Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN): Seek medical help right away if you notice:
+ 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

Common Side Effects

Most people do not experience severe side effects, but may have mild or moderate side effects, such as:

Diarrhea
Upset stomach or vomiting
Decreased appetite
Dizziness
Drowsiness
Fatigue
* Weakness

If any of these side effects bother you or do not go away, contact your doctor.

Reporting Side Effects

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

  • Severe headache, blurred vision, double vision, or vision loss (signs of increased pressure in the brain, pseudotumor cerebri). Seek immediate medical attention.
  • Severe or watery diarrhea, especially if it contains blood or mucus (may be a sign of C. difficile infection).
  • New or worsening dizziness, lightheadedness, or vertigo.
  • Severe skin rash, blistering, peeling skin, fever, swollen lymph nodes, or swelling of the face (signs of a severe allergic reaction or DRESS syndrome). Seek immediate medical attention.
  • Yellowing of the skin or eyes, dark urine, or persistent nausea/vomiting (signs of liver problems).
  • Unusual bleeding or bruising, persistent sore throat, or fever (signs of blood disorders).
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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 doing so while taking this medication.

This list is not exhaustive, and it is crucial to discuss all your medications (including prescription, over-the-counter, natural products, and vitamins) and health issues 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.
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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 second 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.

This medication is typically not recommended for children under 8 years old, except in specific circumstances. If your child is prescribed this medication, discuss the potential risks with your doctor. One possible side effect in children under 8 is a permanent change in tooth color to a yellow-gray-brown hue. If this occurs, it will not be reversible. However, in adults, tooth discoloration has been reported to be reversible after stopping the medication and undergoing dental cleaning.

If you are using birth control pills or other hormone-based contraception, be aware 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.

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, call your poison control center at 1-800-222-1222. Seek emergency medical attention immediately.

Drug Interactions

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Contraindicated Interactions

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

  • Anticoagulants (e.g., Warfarin): May potentiate anticoagulant effects, requiring dose adjustment of the anticoagulant.
  • Penicillins: May interfere with the bactericidal action of penicillin; avoid concomitant use.
  • Ergot alkaloids (e.g., Ergotamine, Dihydroergotamine): Theoretical risk of increased ergot toxicity, though less documented than with macrolides.
  • Live bacterial vaccines (e.g., Typhoid vaccine, BCG): May reduce the therapeutic effect of the vaccine.
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Moderate Interactions

  • Antacids containing aluminum, calcium, or magnesium; iron preparations; bismuth subsalicylate; zinc salts: May decrease minocycline absorption due to chelation. Administer minocycline 2-3 hours before or 4-6 hours after these agents.
  • Oral contraceptives: May decrease the effectiveness of oral contraceptives, leading to breakthrough bleeding or unintended pregnancy. Advise alternative birth control methods.
  • Methotrexate: May increase methotrexate toxicity dueocycline's potential to displace it from protein binding or interfere with renal excretion.
  • Digoxin: May increase digoxin levels in some patients due to alteration of gut flora.
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Minor Interactions

  • Barbiturates (e.g., Phenobarbital), Carbamazepine, Phenytoin: May decrease minocycline half-life due to enzyme induction, potentially reducing efficacy.
  • Diuretics (e.g., Furosemide, Thiazides): May increase the risk of renal toxicity, especially in patients with pre-existing renal impairment.

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 initiation, especially for long-term therapy.

Renal function (BUN, creatinine)

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

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

Complete Blood Count (CBC)

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

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

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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 (BUN, creatinine)

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

Target: Within normal limits.

Action Threshold: Significant decline warrants dose adjustment or discontinuation.

Complete Blood Count (CBC)

Frequency: Periodically for long-term therapy.

Target: Within normal limits.

Action Threshold: Significant abnormalities warrant discontinuation and investigation.

Intracranial pressure (symptoms)

Frequency: Ongoing symptom monitoring.

Target: Not applicable.

Action Threshold: New or worsening headache, blurred vision, diplopia, papilledema require immediate evaluation 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 <8 years)
  • Severe headache, blurred vision, diplopia (signs of pseudotumor cerebri)
  • Severe or persistent diarrhea (may indicate C. difficile-associated diarrhea)
  • Rash, fever, lymphadenopathy, eosinophilia (signs of Drug Reaction with Eosinophilia and Systemic Symptoms - DRESS syndrome)
  • Joint pain, swelling (lupus-like syndrome 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 when administered during the second and third trimesters.

Trimester-Specific Risks:

First Trimester: Limited data, but potential for skeletal and limb abnormalities has been suggested with tetracyclines. Generally avoided.
Second Trimester: Risk of permanent tooth discoloration (yellow-gray-brown) and reversible inhibition of bone growth in the fetus.
Third Trimester: Risk of permanent tooth discoloration (yellow-gray-brown) and reversible inhibition of bone growth in the fetus.
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Lactation

Minocycline is excreted into breast milk. While the amount is generally low and absorption by the infant is limited due to chelation with calcium in milk, 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. Use should be avoided if possible, or the infant should be monitored for adverse effects. Consider alternative antibiotics.

Infant Risk: L3 (Moderate risk - possible adverse effects on infant, but benefits may outweigh risks in some situations).
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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 can be used with caution, typically for severe acne or specific infections where other antibiotics are not suitable.

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Geriatric Use

No specific dosage adjustments are generally required for elderly patients based on age alone. However, elderly patients may be more susceptible to adverse effects such as dizziness/vertigo and may have age-related decline in renal or hepatic function, requiring careful monitoring and potential dose adjustment if impairment is present. Increased risk of C. difficile-associated diarrhea.

Clinical Information

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Clinical Pearls

  • Minocycline is often preferred over other tetracyclines for acne due to its better penetration into sebaceous glands and longer half-life.
  • Unlike other tetracyclines, minocycline's absorption is not significantly affected by food or dairy, but taking it with a full glass of water and remaining upright is crucial to prevent esophageal irritation and ulceration.
  • Dizziness and vertigo are common side effects, especially at the beginning of therapy or with higher doses. Advise patients to be cautious when driving or operating machinery.
  • Long-term use can lead to blue-gray skin, nail, and tooth discoloration, particularly in sun-exposed areas or scars. This discoloration can be permanent.
  • Minocycline has anti-inflammatory properties in addition to its antibacterial effects, which contributes to its efficacy in acne.
  • Monitor for signs of pseudotumor cerebri (benign intracranial hypertension), especially if co-administered with oral retinoids, or if patients report severe headache or vision changes.
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Alternative Therapies

  • Doxycycline (another tetracycline, often used for similar indications)
  • Erythromycin (macrolide antibiotic, for skin infections, respiratory infections)
  • Azithromycin (macrolide antibiotic)
  • Clindamycin (lincosamide antibiotic, for skin and soft tissue infections, acne)
  • Trimethoprim/Sulfamethoxazole (sulfonamide antibiotic)
  • Oral contraceptives (for hormonal acne)
  • Topical retinoids (for acne)
  • Benzoyl peroxide (for acne)
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Cost & Coverage

Average Cost: $20 - $100 per 30 capsules (50mg)
Generic Available: Yes
Insurance Coverage: Tier 1 or 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 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 emergency medical attention. When seeking help, be prepared to provide details about the overdose, including the medication taken, the amount, and the time it occurred.